| Код ТН ВЭД | 804295 |
Как аккредитованная фабрика по производству метакрилатной смолы для углеродных принтеров FotoDent, мы соблюдаем строгие протоколы качества - каждая партия подвергается строгим испытаниям для обеспечения последовательных стандартов эффективности и безопасности.
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Carbon Printers FotoDent tray methacrylate resin is a single-component, light-polymerizing methacrylate photopolymer qualified for the Carbon Digital Light Synthesis (DLS) platform in dental laboratory and clinical milling centers. The formulation is supplied as a ready-to-print liquid; before insertion into the Carbon M2 or L1 cassette bay, the cartridge must be agitated for at least 15 min at 18–25 °C to redisperse any oligomer stratification that occurs during storage. Once loaded, the resin is processed at 100 wt% solids; no reactive diluent, pigment, filler, or rheology modifier is to be introduced at the point of use. The standard post-print workflow comprises a 99% isopropanol immersion for 10–12 min, forced-air drying, and a 405 nm UV LED post-cure at 60 °C for 30–45 min depending on wall thickness. Because residual methacrylate monomer and photoinitiator by-products are known mucosal irritants, printed appliances must not be released for clinical use until the post-cure sequence reduces surface tack and the part passes the ISO 10993-5:2009 cytotoxicity endpoint specified in the respective downstream scenario. The resin is not autoclavable; steam sterilization above 121 °C induces softening and dimensional distortion of the crosslinked methacrylate network. In all downstream applications described below, the terminal appliance is a custom-made dental device subject to the quality system and documentation requirements of the fabricating dental laboratory.
In fixed prosthodontic workflows involving multiple prepared abutments, the printed methacrylate tray functions as a rigid carrier for addition-cure polyvinylsiloxane or polyether impression materials, where uniform material clearance is the dominant variable controlling impression strain. The tray is classified as a short-term, surface-contacting oral mucosal device under ISO 10993-1:2018; cytotoxicity is evaluated by extract testing under ISO 10993-5:2009 using eluate exposure durations of 24 h and 72 h, with the acceptance endpoint defined as cell viability not falling below 70% of the control culture. The formulation is charged at 100 wt% as-supplied methacrylate polymer; digital shell thickness is set to 2.0–2.5 mm with a 1.5 mm offset for impression material, so a full-arch tray consumes 15–25 mL of resin while a quadrant tray consumes 8–12 mL. The downstream process begins with an intraoral scan processed in exocad DentalCAD or 3Shape Dental System; the CAD model applies tissue stops at 0.5 mm relief on prepared abutments to prevent metal or subgingival tray impingement. The STL is transferred to the Carbon M2 or L1 printer; build platform orientation and support generation follow resin-specific shear stress thresholds at the DLS oxygen-permeable membrane, with slice thickness held at 50 µm. After printing, the tray is immersed in 99% IPA for 10 min, air-dried, and post-cured at 60 °C for 40 min under a 405 nm LED array. Supports are removed with side cutters, and the intaglio surface is inspected for build lines and residual polymerized flash before loading. The terminal product is a dimensionally stable custom impression tray for crown-and-bridge pick-up impressions; it is compatible with automixed polyvinylsiloxane and high-rigidity polyether systems, and its rigidity is sufficient to resist flexure during one-step, two-stage putty-wash protocols.
Because edentulous arch geometry introduces peripheral seal variance that cannot be managed with stock trays, the printed methacrylate tray is designed with extended borders that require tactile border molding with a low-fusing thermoplastic compound before the final polyvinylsiloxane wash. The critical processing window is the post-cure thermal profile: exposure at 60 °C for fewer than 30 min produces an under-converted methacrylate network with residual monomer above the 0.5 wt% threshold commonly applied to intraoral short-term devices, while autoclave cycles above 121 °C exceed the practical use temperature because the crosslinked network begins to soften near the glass transition of 80–95 °C typical of this polymer class. Published data for this specific configuration is limited; however, production-scale process engineering requires the post-cure oven to be monitored with a Type K thermocouple in contact with the build plate to hold stray thermal stratification within ±3 °C. Dimensional stability is tested under ISO 20795-1:2013 by water immersion at 37 °C for 7 days; linear change must not exceed 1.5% for the tray to remain compatible with subsequent border molding. The resin remains a 100 wt% single-component formulation; border extension segments are built directly from the same resin rather than bonded as secondary additions. Resin consumption for a maxillary edentulous tray is 25–35 mL, with printed mass approximately 20% higher than a dentate full-arch tray due to increased border width and thickness. The manufacturing sequence transfers a scanned preliminary cast into CAD; the tray is shelled to 2.5–3.0 mm body thickness, 4.0 mm border thickness, and 0.8 mm relief over the residual ridge crest. On the Carbon M2, build orientation includes an anterior tilt of 20° to reduce suction forces at the oxygen-permeable membrane; slice thickness is 100 µm in border regions and 50 µm on the intaglio. After printing, the tray is washed in a two-stage IPA cascade (10 min primary, 3 min secondary), dried, and post-cured at 60 °C for 45 min. Border molding proceeds with green stick tracing compound applied to the periphery, followed by a medium-bodied polyvinylsiloxane or polyether final wash. The terminal outcome is a border-molded edentulous impression tray used to record complete denture functional impressions under controlled masticatory loading; hard palate support prevents mid-palatal flexure, and the intaglio accepts a uniform 2 mm wash of impression material.
The following standards matrix maps the compliance endpoints applicable across the edentulous tray workflow and subsequent tray categories:
| Standard designation | Test method / clause | Process checkpoint | Endpoint / parameter |
|---|---|---|---|
| ISO 10993-1:2018 | Biological evaluation planning | Material qualification | Short-term oral mucosal contact category |
| ISO 10993-5:2009 | In vitro cytotoxicity | Post-cure batch release | Cell viability endpoint |
| ISO 10993-10:2010 | Skin sensitization / irritation | Biocompatibility file | Oral mucosa irritation scoring |
| ISO 20795-1:2013 | Water immersion dimensional change | Incoming quality control | Linear change ≤ 1.5% |
| ISO 178:2019 | Three-point flexural bending | Mechanical validation | Flexural modulus and strength |
| ISO 10993-12:2012 | Sample extraction for leachables | Chemical residue analysis | Monomer leachable profile |
The chemical compatibility question is addressed through leachable analysis rather than clinical assumption: the tray wall is a crosslinked methacrylate polymer in direct contact with a 10–16% carbamide peroxide or 6% hydrogen peroxide gel for 60–120 min per session across 14–21 days, and peroxide species can attack the ester linkages of methacrylate networks if monomer conversion is incomplete. Leachables are extracted per ISO 10993-12:2012 at 37 °C for 72 h and quantified by gas chromatography–mass spectrometry; total residual methacrylate monomers must remain below 5 ppm, and bisphenol A diglycidyl methacrylate derivatives below 0.5 ppm. Cytotoxicity of the leachate is scored under ISO 10993-5:2009 quantitative MTT endpoint; a viability reduction greater than 30% at 100% extract concentration indicates incompatibility with the bleaching application. The methacrylate tray itself constitutes 100 wt% of the custom holder; buccal gel reservoir volume is governed by a digital spacer offset of 0.5–1.0 mm on the labial surfaces, yielding approximately 0.3 mL of gel capacity per arch. In the total nightly treatment system, the tray contributes 90–95 wt% and the peroxide gel 5–10 wt% of appliance mass. The downstream process starts with a diagnostic cast and undercut blockout; a 0.5 mm resin spacer is applied to the buccal surfaces before scanning so the resulting tray creates a uniform gel reservoir while avoiding scalloped incisal coverage that would irritate the gingival margin. The tray is printed at 25 µm z-resolution on the Carbon DLS to reproduce spacer boundaries; washing uses 99% IPA for 10 min, followed by air-drying and a 60 °C post-cure for 30 min. Final trim is performed with a carbide bur at 15,000–20,000 rpm to reduce gingival height to 0.5 mm, and margins are polished with a silicone point to prevent soft-tissue abrasion. The terminal product is a custom home-bleaching tray that maintains dimensional accuracy across repeated peroxide exposure cycles; it is supplied to the patient with reservoirs pre-loaded with carbamide peroxide gel at the clinician-specified concentration.
For in-office topical fluoride delivery, the service environment is acidulated phosphate fluoride at 1.23% or neutral sodium fluoride at 2%, not neutral peroxide or polyvinylsiloxane contact, so the printed methacrylate tray must be evaluated under a separate chemical resistance profile. The tray body is assessed under ISO 10993-1:2018 as a short-term surface-contacting device; a validated reprocessing protocol is required under EN ISO 17664:2017 if the tray is reused across patients, and production-scale observations indicate that 2.5% glutaraldehyde immersion must be limited to 10 min because longer exposure induces surface hazing and localized network swelling of the methacrylate polymer. Preferred disinfection uses 70% isopropanol or quaternary ammonium compounds applied by spray-and-wipe, followed by a sterile water rinse and oil-free compressed-air drying. The resin-to-appliance ratio remains 100 wt% polymerized methacrylate; tray thickness is set to 1.5–2.0 mm to balance rigidity against gel capacity, and gel loading is 2–3 mL per tray. The resin does not contain fluoride additives, so no formulation adjustment is required for fluoride compatibility; however, the post-cure schedule is extended to 35 min at 60 °C to lower residual surface ester content that may interact with low-pH fluoride gels. The downstream process shells the CAD model from an intraoral scan, prints at 50 µm slice thickness on the Carbon M2, and uses a two-stage solvent cascade of tripropylene glycol methyl ether followed by IPA for a combined 18 min wash. Disinfection prior to patient use is completed with quaternary ammonium spray, water rinse, and drying; the tray is then inspected for delamination and surface roughness before forceps placement over the dentition. The terminal device is a reusable or single-use fluoride application tray for professional topical fluoride gel treatment, with internal surface ridges optionally included to retain gel against the enamel during the 4 min professional contact period.
Open-window tray designs eliminate the need to remove the tray before unscrewing pick-up copings, but they impose local stress concentrations at window corners that require the methacrylate network to maintain fracture resistance at thicknesses below 1.5 mm. The tray is a Class I custom-made device under EU MDR 2017/745 with short-term oral mucosal contact; biological evaluation follows ISO 10993-1:2018 and ISO 7405:2018, and mechanical verification of window-corner integrity uses ISO 178:2019 three-point flexural testing on 2.0 mm specimens. The resin is applied at 100 wt% without thinning; window margins are reinforced by locally increasing wall thickness to 3.0 mm, consuming 15–25% additional resin volume per tray compared with a closed-mouth design. The CAD workflow begins with a digital scan of implant positions obtained from an implant-level impression; the tray is shelled with a rectangular access opening of 6 mm × 6 mm over each screw channel, and the build is oriented with windows parallel to the DLS build plane to reduce support failure. Slice thickness is 50 µm; after printing, the tray is washed in 99% IPA for 12 min and post-cured at 60 °C for 40 min. Open-window edges are smoothed with a scalpel and diamond-coated finishing strip to prevent polyvinylsiloxane tearing at the pick-up coping interface. The terminal product is an open-window implant impression tray for multi-unit screw-retained prosthetics; it is used with implant-level impression copings and high-rigidity polyether such as Impregum, where the tray must resist flexure while the operator unscrews copings through the access windows.
For orthodontic adhesive-curing workflows, the transfer tray floor must transmit visible light without compromising slot accuracy, a condition that directly constrains methacrylate resin translucency and floor thickness. The polymerized tray is evaluated under ISO 20795-2:2013 for flexural modulus and residual monomer content, and biocompatibility is assigned under ISO 10993-1:2018 as an oral mucosal short-term contact device. Light transmittance in the 420–490 nm region must permit cure-through-tray adhesive polymerization; published data for this specific configuration is limited, so each production batch should be verified with a MARC Light Collector on a 1.5 mm specimen before bracket transfer use. The undiluted methacrylate resin comprises 100 wt% of the transfer tray body; tray floor thickness is 0.6–1.0 mm over bracket slots and 1.5 mm over occlusal surfaces, and no particulate filler addition is permitted because translucency requirements conflict with inorganic loading above 1.0 wt%. The downstream process creates a digital setup by aligning brackets on the maloccluded scan; the tray is designed with labial cutouts that expose bracket wings for flash removal after transfer. Printing uses 25 µm z-resolution on the Carbon DLS, followed by a 99% IPA wash for 10 min and a 50 °C post-cure for 20 min to avoid embrittlement of thin floor sections. Brackets are loaded into the tray with light-cured orthodontic adhesive, the tray is seated onto prepared enamel, and curing is performed from occlusal and labial directions. The terminal product is a single-use indirect bonding transfer tray for fixed orthodontic appliance placement; it positions 20–24 brackets in a single arch transfer with slot accuracy retained within 0.1 mm after printing, washing, and post-cure.
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FotoDent tray is a methacrylate-based photopolymer resin whose model designation is used for additively manufactured custom impression trays on digital light processing hardware and on Carbon DLS systems operating with a compatible open material profile. The uncured liquid is formulated around multifunctional methacrylate esters and a photoinitiator package; the cured network is intended to provide rigid support for vinyl polysiloxane and polyether impression materials without introducing clinically significant tray flexure. The material is supplied for short-term mucosal contact applications, and the finished tray is normally assessed within a biological evaluation framework derived from ISO 10993-1:2018. Because the exact formulation is proprietary, the supplier’s batch certificate and current technical data sheet should be treated as the controlling specification; published data for this specific resin-Carbon DLS configuration is limited. The resin should be handled as a chemical product under REACH Regulation (EC) No 1907/2006 before polymerization, and the printed tray should be treated as a custom-made device under the quality system requirements of ISO 13485:2016 where applicable.
In the digital workflow, the intraoral scan is used to design the tray shell with an offset that accommodates the selected impression material. The model is printed with a printer-specific layer thickness; open-platform DLP and LCD systems often operate between 50 μm and 100 μm, whereas Carbon DLS equipment uses a continuous liquid interface in which the polymerization front is maintained above an oxygen-permeable optical window. After the build, the tray is removed from the platform, drained, and cleaned in a two-stage solvent bath to remove unpolymerized resin from undercuts and internal channels. The cleaned tray is then dried and post-cured with a UV/LED source whose spectral output overlaps the resin’s photoinitiator absorption. The final tray should be inspected for support remnants, sharp edges, delamination, and resin pooling before terminal disinfection. Processing parameters should be locked to the resin manufacturer’s validation document for the exact printer model and resin revision.
The flexural behaviour of the cured tray is controlled by the degree of conversion of methacrylate double bonds and the resulting crosslink density. Under-cured regions contain residual monomer that can plasticise the network, lower the glass transition temperature, and increase creep when the tray is seated under clinical force. The degree of conversion can be monitored on laboratory samples by Fourier-transform infrared spectroscopy using the methacrylate C=C absorbance near 1637 cm⁻¹ against a stable reference band. Post-cure time and irradiance are the dominant variables; extending post-cure from approximately 5 minutes to 20 minutes under a matched 405 nm LED source increases conversion in many dental methacrylate formulations, but the plateau depends on filler content, initiator concentration, and part geometry. Flexural properties of the final tray should be measured according to ISO 20795-1:2013 or ISO 178:2019, not inferred from Shore D hardness alone. If post-cure is performed in air, oxygen inhibition can leave a tacky surface layer with unreacted monomer; the protocol should therefore specify either an inert gas blanket, an additional solvent wipe, or a final inert post-cure step to avoid transferring unpolymerized methacrylate to the oral environment.
Carbon DLS systems establish a continuously replenished dead zone between the build surface and the oxygen-permeable window. A methacrylate resin formulated for conventional DLP or LCD printing does not automatically match the oxygen flux, inhibitor consumption, and light absorption requirements of this process. Without a locked material profile, the operator must confirm that the resin’s critical energy dose, cure depth, and recoat behaviour are matched to the projector irradiance and the optical window. Excessive exposure can push the polymerization front into the dead zone and produce window adhesion, while insufficient exposure reduces green strength and can generate delamination in thin buccal or lingual extensions. Production-scale Carbon DLS lines have shown that stepwise qualification of exposure dose, chamber temperature, resin fill level, and build platform preparation is required when an open material mode is used. The qualification should be documented under ISO 13485:2016 and should include a worst-case build layout to test edge-to-edge irradiance uniformity. Clinical use should not begin until the resin-printer combination has passed dimensional, mechanical, and biological acceptance criteria.
Uncured resin conditioning is a frequent source of batch-to-batch processing variability. Cold resin exhibits higher viscosity and may leave uneven recoat films, producing edge curl or incomplete fill in thin tray extensions. The bottle should be conditioned for at least 2 hours at the printer manufacturer’s specified resin temperature before the build. Viscosity is shear-rate dependent; cone-plate rheometry at 25 °C is commonly used to document batch quality. In continuous DLS, viscosity affects resin replenishment beneath the build, especially around the tray periphery. A viscosity that falls outside the approved range may create microvoids or reduce green strength. The build platform and resin tray should also be inspected for debris, polymerized films, and scratches; a single polymerized particle can interfere with the oxygen-permeable window and alter the local dead zone. Used resin should be filtered through a sieve of 100 μm or finer after each build to remove partially gelled material, and the resin pot should be checked for crystallization or solvent contamination. The resin should not be thinned with solvents, blended with other photopolymers, or exposed to amine-based accelerators, because amines can trigger premature methacrylate crosslinking and produce exothermic gelation in the storage container.
Support placement on the intaglio surface is generally avoided because support scars can affect tray fit and impression material adhesion. Buccal and lingual flanges should be oriented to minimize large unsupported overhangs that may deform during the build. On Carbon DLS equipment, the continuous motion makes orientation less dependent on layered peel forces than in conventional DLP, but the resin’s green modulus still governs the maximum unsupported length before sagging. Validation builds should include a representative full-arch tray and an extreme narrow tray to verify that support settings do not produce excessive deflection.
Cleaning and post-curing are the two process variables most likely to alter final tray fit and surface quality. Residual unpolymerized resin left in internal undercuts can undergo slow secondary polymerization during storage and produce dimensional drift. The tray should be cleaned until no visible film remains, dried with oil-free compressed air, and moved immediately to the post-cure chamber to avoid ambient light-induced surface cure. Alcohol-based cleaning solvents should be monitored for water uptake and resin loading; a two-stage bath arrangement is preferred, with the first bath removing gross resin and the second bath removing the dilute residual film. Incomplete solvent evaporation before post-cure can create bubbles and surface haze. The post-cure unit’s emission spectrum should overlap the resin’s photoinitiator absorption; a chamber with a 405 nm LED peak may not fully cure a resin whose initiator requires 385 nm for maximum efficiency. The chamber temperature should not exceed the resin manufacturer’s limit, commonly below 60 °C, because differential thermal expansion in thick portions can warp the tray during cooling. A calibrated radiometer should be used to verify the chamber irradiance; an aged LED array that has fallen below the resin’s minimum dose cannot be compensated simply by extending time if the spectrum has shifted. The finished tray should be stored dry at 10–25 °C and protected from direct sunlight to minimize auto-oxidation of the polymer surface.
Custom tray fit is evaluated by superimposing the printed intaglio surface onto the original CAD model using best-fit alignment. Clinical acceptance protocols often set a deviatoric envelope of ± 100 μm for the axial walls and somewhat larger tolerances for the handle, where support removal creates local surface alteration. The resin’s polymerization shrinkage and stress relaxation determine whether the tray remains within this envelope after post-cure and storage. Methacrylate photopolymers typically exhibit volumetric shrinkage in the range of 2–8 % depending on filler content, monomer functionality, and conversion; the exact value for the FotoDent tray revision in use should be obtained from the batch certificate or technical data sheet. Tear surface at support separation is a useful quality marker. A brittle fracture may indicate a highly crosslinked but notch-sensitive network, whereas ductile tearing may indicate incomplete conversion or residual solvent. Under a digital microscope, the intaglio surface should not show layer stair-stepping beyond the printer’s nominal z-resolution. Surface roughness can be characterized according to ISO 4287:1997; rougher intaglio surfaces may increase mechanical retention of impression material but may also complicate cleaning and disinfection.
| Area | Standard or framework | Application in resin and tray validation |
|---|---|---|
| Biological evaluation | ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010 | Cytotoxicity, irritation, and sensitization assessment for short-term mucosal contact |
| Mechanical properties | ISO 20795-1:2013, ISO 178:2019 | Flexural performance and comparison among methacrylate dental polymers |
| Surface characterization | ISO 4287:1997 | Roughness measurement of printed intaglio surfaces |
| Quality management | ISO 13485:2016 | Process control for dental laboratory manufacturing |
| Chemical safety | REACH Regulation (EC) No 1907/2006, RoHS Directive 2011/65/EU | Uncured resin handling and restricted substance documentation |
| Device regulatory framework | EU MDR 2017/745 | Custom-made dental device classification and technical documentation |
From a regulatory standpoint, a custom impression tray printed from this methacrylate resin is a custom-made dental device in many jurisdictions. The final device must be produced under a quality management system aligned with ISO 13485:2016 and, where applicable, EU MDR 2017/745. The resin supplier’s biological test data may support short-term mucosal contact, but the final device’s conformity remains the responsibility of the dental laboratory or device manufacturer. Traceability should include the resin lot number, printer serial number, cleaning solution lot, post-cure cycle identifier, and final visual inspection record. The product is not indicated for permanent restoration, long-term implant surgical positioning, or use as a definitive splint unless a separate regulatory and clinical evaluation is completed.
Compared with conventional autopolymerizing tray acrylics, the methacrylate photopolymer removes manual powder-liquid mixing and its associated batch variability, but it introduces a post-cure step and a narrower handling window for uncured resin. Compared with dental model resins, the tray resin is intended for short-term mucosal contact and is selected for higher flexural stiffness and documented biological evaluation. Compared with bis-acryl and UDMA-based photopolymers, the methacrylate network may show a different balance between rigidity and fracture toughness; material selection should therefore be based on ISO 20795-1:2013 flexural data and ISO 10993-5:2009 cytotoxicity results for the exact printer-resin combination. The resin is incompatible with amine-containing accelerators and uncured composite residues, which can initiate premature redox polymerization or alter the photopolymerization profile. It should not be blended with solvents or other resin families unless the manufacturer’s technical data sheet explicitly permits that modification. Printed trays should be evaluated with the intended impression material, because polyether and vinyl polysiloxane materials place different adhesive and shelf-life demands on the tray surface.