| Код ТН ВЭД | 276890 |
Как аккредитованный завод Proto3000 Formlabs Dental LT Clear Resin, V2, мы соблюдаем строгие протоколы качества - каждая партия подвергается строгим испытаниям для обеспечения последовательных стандартов эффективности и безопасности.
| Упаковка | One 1 L amber bottle of Proto3000 Formlabs Dental LT Clear Resin, V2, sealed inside a labeled cardboard box. |
| Погрузка контейнера (20-футовый контейнер) | 20′ FCL container loading: Proto3000 Formlabs Dental LT Clear Resin V2, palletized, shrink-wrapped, labeled, and secured for safe ocean transport. |
| Доставка | Proto3000 Formlabs Dental LT Clear Resin, V2 is shipped as a non-regulated, non-hazardous liquid. Standard ground or air transport is acceptable, with no UN number, hazard class, packing group, labels, or placards required. Keep containers sealed, upright, and protected from heat and light; follow the SDS and local rules. |
| Хранение | Store Proto3000 Formlabs Dental LT Clear Resin, V2 in its original, tightly closed container, upright, in a cool, dry, well-ventilated area. Protect from direct sunlight, UV light, heat, sparks, flames, moisture, and incompatible materials. Maintain recommended temperature, typically 18–28°C (65–86°F); do not freeze. Keep out of reach of children and follow the SDS. Use secondary containment and keep containers closed when not in use. |
| Срок годности | Shelf life: 2 years (24 months) when stored unopened in original container under recommended conditions, away from heat, light, and moisture. |
Flat-plane occlusal stabilization splints printed from Proto3000 Formlabs Dental LT Clear Resin V2 are fabricated as single-component appliances without blending the resin with any other grade, reactive diluent, or filler system; the resin is used at 100 wt% as supplied in the cartridge. On 405 nm laser stereolithography platforms, the standard z-axis layer height is 100 µm, and the intaglio surface is oriented support-free to preserve fit against the maxillary or mandibular arch. Supports are confined to buccal cusps and incisal edges to avoid leaving spurs on the tissue-bearing surface. After printing, excess resin is removed in 99% isopropyl alcohol using a Form Wash for 10 min, followed by post-cure in a Form Cure at 60°C for 60 min. The solvent bath must be replaced before suspended oligomer raises surface tack, because inadequately washed appliances can retain residual monomer and compromise the extraction profile described under ISO 10993-5:2009 and ISO 10993-10:2010. The cured splint is finished with acrylic cross-cut burs and polishing wheels under intermittent handpiece pressure to limit frictional heating; final surface roughness below 0.2 µm Ra is targeted because higher roughness increases plaque adhesion on long-term intraoral appliances. Under EU MDR 2017/745, the resin is supplied for fabrication of Class IIa long-term dental devices, and material biocompatibility is assessed within the framework of ISO 10993-1:2018 and ISO 7405:2018. Mechanical conformity for orthodontic base polymers is verified under ISO 20795-2:2013; however, published batch-specific data for this exact resin configuration is limited, so laboratory flexural testing is recommended before release. The final occlusal guard is stored dry at room temperature and is not autoclaved, because steam processing at 121°C thermally distorts the crosslinked methacrylate network and destroys occlusal contact accuracy.
Direct-printed clear orthodontic retainers use the same neat resin ratio and build orientation principles as occlusal splints, but the fit tolerance is narrower because retention depends on mechanical engagement between the printed shell and clinical crown anatomy rather than on adhesive bonding. The as-printed retainer is washed in 99% isopropanol for 10 min and post-cured at 60°C for 60 min; any batch that bypasses the full post-cure cycle retains unreacted methacrylate species and shows reduced elastic recovery under ISO 20795-2:2013 flexural loading. Fit deviation after post-cure is evaluated by seating the retainer on a digital model or verified stone cast, and marginal lift at the gingival third is treated as a process defect when it exceeds the calibrated scanner error of the laboratory. Undercured, solvent-trapped, or partially washed devices frequently show an opaque white surface after polishing, which indicates phase separation of residual isopropanol and crosslinked polymer rather than a clinically harmless surface haze. The retainer is not lined with soft silicone and no adhesive is placed on the intaglio surface; retention is achieved entirely through undercut engagement and flexural stiffness. Because thermal softening occurs before visible deformation, high-speed adjustment without water irrigation is prohibited. Biocompatibility under ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 applies only after complete post-cure; uncured or partially cured surfaces must not contact oral mucosa. The final appliance is delivered as a single-piece clear retainer with no mixed resin components and no chairside reline material.
| Standard | Scope | Application checkpoint |
|---|---|---|
| ISO 10993-1:2018 | Biological evaluation planning | Class IIa long-term mucosal contact device |
| ISO 10993-5:2009 | Cytotoxicity | Finished-device extract testing after full post-cure |
| ISO 10993-10:2010 | Skin sensitization and irritation | Polished intaglio and external surfaces |
| ISO 10993-11:2017 | Systemic toxicity | Leachable fraction from washed and cured resin |
| ISO 7405:2018 | Dental device biocompatibility | Intraoral contact with intact mucosa and saliva |
| ISO 20795-2:2013 | Orthodontic base polymers | Flexural strength, modulus, and water-immersion stability |
For temporomandibular joint repositioning appliances, the load path shifts from uniform cusp-to-cusp contact to localized incisal and posterior pivots, which imposes higher local flexural stress on the printed base. Proto3000 Formlabs Dental LT Clear Resin V2 is processed at the same 100 µm z-resolution and washed in 99% isopropyl alcohol for 10 min; post-cure remains at 60°C for 60 min. However, the base thickness under the protrusive ramps must not be reduced below 1.5 mm in the design file because thinner cross-sections create stress concentration at the junction of the ramp and the palatal or lingual flange. Chairside adjustment uses a low-speed handpiece with continuous water irrigation; dry grinding introduces surface microcracks that propagate under cyclic bruxism loading and shorten service life. The appliance is not constructed by mixing the hard clear resin with a soft liner resin in the same print job; any attempt to overprint or laminate different material classes creates an interfacial zone with dissimilar conversion shrinkage and may delaminate under repetitive anterior guidance. For diagnostic mounting, the printed appliance is seated on an articulator after occlusal adjustment, and articulation paper contacts are balanced according to the clinician’s occlusal scheme. The material is not intended for heat-mold reshaping after curing. ISO 20795-2:2013 water-immersion conditioning is used to assess the effect of intraoral water uptake on flexural properties before batch release, but published data for this specific product configuration is limited, so laboratory controls should include a water-immersion flexural test using finished coupons from the same build platform.
Clear resin removable appliances are disinfected in clinical and laboratory settings without autoclaving. Steam sterilization at 121°C or dry heat at 160°C is prohibited for Proto3000 Formlabs Dental LT Clear Resin V2 because the cured methacrylate network is not thermoplastically stable at those temperatures and warpage at the palatal vault has been observed on laboratory dry-heat trials. Chemical disinfection should follow the manufacturer’s instructions for use; short-contact non-oxidizing aqueous disinfectants are used within the recommended exposure times, while strong oxidizing agents, ketones, and aromatic solvents are avoided because they stress-craze the polymer surface. Repair or reline with auto-polymerizing acrylic requires mechanical preparation of the printed surface and a bonding agent based on methyl methacrylate or a compatible methacrylate system; published data for the specific bond strength between this resin and chairside reline materials is limited, so a repair should not be considered acceptable for long-term load-bearing regions without additional mechanical retention features. The finished repair must be inspected under magnification for white stress fractures, and if any craze extends through the full wall thickness, the device is rejected. The same protocol applies to night guards adjusted with composite occlusal stops; composite is added only after the printed surface is roughened with a fine diamond and wetted with a methacrylate bonding primer. Excess monomer from the repair must not remain on the intaglio surface, because residual monomer can initiate mucosal irritation and invalidate the ISO 10993-10:2010 sensitization profile of the finished device.
Full-arch night guards with selective occlusal load windows are built with different wall thicknesses in posterior and anterior regions to redirect masticatory force away from restored or periodontally compromised teeth. The resin is processed neat at 100%, and no dilution with isopropanol is performed before printing because even small alcohol fractions disrupt the photopolymerization gel point and reduce crosslink density. Posterior occlusal thickness is set to 2.0–2.5 mm in the CAD file; anterior guidance planes are designed at 1.0–1.5 mm. These dimensions are design variables, not material limits, and must be verified on the printed part with a calibrated thickness gauge before post-cure. The printed device is washed and post-cured according to the same protocol: 10 min in 99% isopropyl alcohol, followed by 60 min at 60°C. Selective load windows increase local stress in the posterior region, so the laboratory should inspect the junction where cross-section thickness changes for layer delamination or internal haze. If supports are placed on the occlusal surface, support removal must not create notches deeper than 0.2 mm in the load window; any notch becomes a crack initiator under cyclic masticatory force. The final appliance is polished to a high gloss, and the patient is instructed not to soak the guard in water above 50°C or leave it in a closed vehicle in summer, because thermal softening reduces the intended occlusal contact pattern and compromises the designed load distribution.
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Proto3000 distributes Formlabs Dental LT Clear Resin V2 as a photo-crosslinking methacrylate photopolymer developed for additive manufacturing of removable dental appliances with long-term intraoral contact. The resin is supplied in 1 L cartridges and is validated for use with Formlabs Form 3B, Form 3B+, and Form 4B printers at 100 µm layer thickness. Manufacturer-intended indications include occlusal splints, night guards, and indirect bonding trays. Final device classification is established by the dental laboratory or prescribing clinician under the applicable medical device framework; the resin forms part of a Class IIa workflow under EU MDR 2017/745 when processed with the specified equipment and post-curing protocol.
The uncured liquid is a clear, solvent-free formulation containing methacrylate monomers, a photoinitiator system, and optical clarity additives. Because the material relies on radical chain-growth polymerization, dimensional accuracy depends on controlled radiant exposure, resin temperature, and post-cure thermal history. After opening, the cartridge should remain sealed in the printer or in an opaque container at 10–25 °C. The manufacturer-stated unopened shelf life is 24 months from the date of manufacture.
Photopolymerization is initiated at 405 nm in the printer build chamber. At the validated 100 µm layer height, the incident energy density must remain within the manufacturer-defined process window to control cure depth and avoid overcure that would close small features such as retention grooves or vent channels. Oxygen at the resin surface inhibits free-radical polymerization and produces a thin uncured layer that improves interlayer adhesion but limits conversion at the outermost surface of each layer. The consequence is that as-printed parts retain residual monomer and a soft, tacky surface until solvent washing and post-curing complete the conversion plateau.
The resin is formulated with a viscosity profile compatible with the recoating mechanism of the Form 3B/3B+ and Form 4B build chambers. At working temperature, the liquid forms a smooth recoated layer without excessive meniscus or bubble entrapment. Viscosity increases at storage temperatures below 10 °C; cartridges should be brought to room temperature before shaking and insertion. Shaking is required to redisperse settled additives, but aggressive shaking can introduce microbubbles that persist through the build and create voids in thin splint sections.
Washing is performed in 99% isopropyl alcohol using a Form Wash or equivalent agitation device. The manufacturer-validated wash time is 10 minutes. Manual washing requires longer solvent contact and may introduce dimensional variability. Under-washing leaves uncured monomer at the surface, which acts as a plasticizer and lowers Shore D hardness. Over-washing beyond 20 minutes can embrittle thin sections and cause solvent uptake that expands the part before post-cure. After washing, the appliance is air-dried to constant mass before being placed in a Form Cure.
Post-curing is performed at 60 °C for 20 minutes under 405 nm light. The thermal and optical conditions are coupled: at temperatures below 50 °C, chain mobility is insufficient to reach the designed degree of conversion within the standard cure time, leaving residual monomer above the expected post-cure plateau. At temperatures above 70 °C, the clear matrix begins to show visible yellowing, and thin sections may distort under thermal stress. The 60 °C setpoint is therefore a narrow process control point, and post-cure oven calibration should be verified with a validated temperature probe before production batches are released.
Production-scale failures observed on additive dental lines most often involve support detachment during the first 2 mm of build, caused by insufficient support tip contact diameter or a degraded build platform surface. The PreForm software applies default support dimensions for Dental LT Clear V2; manual reduction of support tip contact diameter below the default profile increases the risk of part loss during peel forces. Recoating defects also occur when resin temperature falls below 20 °C, because viscosity rises and the recoater blade cannot produce a uniform layer. Laboratories operating in cold environments should pre-warm the cartridge to 25 °C and allow the printer to reach thermal equilibrium before the first build.
Typical mechanical properties are reported by the manufacturer for post-cured specimens using ASTM and ISO test methods. The values in Table 1 are not clinical performance limits but serve as batch-release and design-input references for dental laboratories.
| Property | Test Method | Typical Value |
|---|---|---|
| Ultimate tensile strength | ASTM D638-14 | 47 MPa |
| Tensile modulus | ASTM D638-14 | 1.9 GPa |
| Elongation at break | ASTM D638-14 | 6.5% |
| Flexural strength | ASTM D790-15 | 75 MPa |
| Flexural modulus | ASTM D790-15 | 2.1 GPa |
| Notched Izod impact | ASTM D256-10 | 20 J/m |
| Shore D hardness | ASTM D2240-15 | 86 |
| Water sorption | ISO 4049:2019 | 18.6 µg/mm³ |
| Heat deflection temperature at 0.45 MPa | ASTM D648-16 | 69 °C |
The Shore D hardness of 86 places the material in the rigid splint category. The water sorption value of 18.6 µg/mm³ is lower than the 32 µg/mm³ maximum specified for heat-cured denture base polymers under ISO 20795-1:2013, which supports dimensional stability under humid intraoral conditions. Water sorption is measured on standardized coupons, and thin anterior guidance features may still exhibit measurable dimensional change after prolonged soaking in aqueous cleaning solutions. Steam autoclave cycles are not recommended because repeated heat exposure above the heat deflection temperature of 69 °C can distort thin margins and increase opacity.
Test coupons printed in the XY plane typically show higher tensile and flexural strength than coupons printed in the Z-axis. This anisotropy results from interlayer polymerization and is not eliminated by post-curing. When an occlusal splint is loaded in the posterior region, tensile stresses can concentrate along interlayer boundaries at the cervical third of the appliance. The dental technician should therefore add reinforcement to connectors between anterior and posterior segments for bruxing patients and avoid sharp internal notches that act as stress risers.
For occlusal splint production, the digital model is commonly oriented with the intaglio surface facing away from supports and the occlusal surface angled between 60° and 80° to reduce layer lines on functional cusps. Support contact points are placed on non-functional surfaces to minimize post-processing scars. Many laboratories remove supports before post-cure to reduce fracture at the support interface. The cured appliance is finished with tungsten carbide burs and polished with a dedicated acrylic polishing compound to achieve a clinically acceptable surface roughness, typically below 0.2 µm Ra after final polishing. The clear matrix permits visual inspection of internal porosity, support remnants, and fit against the working model.
The material is contraindicated for permanent restorations, fixed prostheses, denture bases, and applications requiring cementation to tooth structure. It is not intended for direct intraoral printing or for patients with known methacrylate hypersensitivity unless a qualified dental professional determines that the benefit outweighs the risk. The uncured resin is a skin and respiratory sensitizer; handling requires nitrile gloves, safety eyewear, and local exhaust ventilation in accordance with the safety data sheet.
Conventional heat-cured polymethyl methacrylate appliances rely on flasking, wax elimination, and thermal polymerization cycles that produce near-isotropic mechanical properties. Dental LT Clear Resin V2 is fabricated layer by layer, which introduces anisotropy in the Z-axis. The manufacturer-reported flexural modulus of 2.1 GPa is close to the lower bound of the 2.0–3.0 GPa range typical of heat-cured PMMA base polymers, while the water sorption value of 18.6 µg/mm³ is below the 32 µg/mm³ limit in ISO 20795-1:2013. These properties support rigid splint therapy, but the appliance design must account for lower Z-axis tensile strength and for stress concentrations created by support remnants on the intaglio surface.
The printed workflow eliminates the thermal expansion and mixing variability associated with laboratory acrylics, but introduces new failure modes related to laser spot size, optical window cleanliness, and solvent purity. Batch-to-batch variance in a dental laboratory is controlled by printing a standard test coupon alongside each build and verifying flexural strength or Shore D hardness before the appliance is delivered. Printed devices also show anisotropic wear behavior; cyclic occlusal loading can propagate microcracks along interlayer boundaries if the post-cure conversion is incomplete. Published long-term clinical wear data for this specific resin configuration is limited, so laboratories should monitor occlusal wear in patients with bruxism and adjust recall intervals accordingly.
In comparison with the previous Dental LT Clear Resin formulation, V2 is the current production SKU and is selected by PreForm when the cartridge is loaded. The two formulations should not be mixed in the same resin tray because the photoinitiator concentration and post-cure schedule differ. Compared with Dental LT Comfort Resin, which has a lower Shore D hardness and higher elongation for flexible night guards, Dental LT Clear V2 is a rigid clear matrix suitable for hard occlusal splints and indirect bonding trays. Compared with Surgical Guide Resin, which is intended for short-term intraoperative use and has a lower elongation at break, Dental LT Clear V2 is indicated for long-term removable appliances and should not be used as a substitute where high-temperature autoclaving or radiographic opacity is required.
Relative to dental cast resins used for sacrificial patterns, Dental LT Clear V2 contains no castable fillers and leaves a higher ash residue, so it is not indicated for burnout applications. Relative to model resins, it has higher elongation and is not formulated for repeated stone model replication. Relative to temporary crown resins, it is not optimized for colour masking or cementation surfaces. These differences are defined by intended use rather than by any single physical property.
| Standard | Scope | Application |
|---|---|---|
| ISO 10993-5:2009 | Biological evaluation of medical devices — cytotoxicity | Material biocompatibility endpoint |
| ISO 10993-10:2010 | Sensitization and irritation | Mucosal contact risk assessment |
| ISO 7405:2018 | Preclinical evaluation of dental medical devices | Finished appliance biocompatibility evaluation |
| ISO 13485:2016 | Quality management for medical devices | Manufacturing site quality system |
| ISO 20795-1:2013 | Denture base polymers | Water sorption comparison |
| ASTM D638-14 | Tensile testing of plastics | Mechanical design inputs |
The material is therefore specified for digital dental laboratories that produce rigid, transparent, removable appliances from intraoral scans or poured models, provided that the post-curing equipment can maintain a calibrated 60 °C setpoint and the solvent wash is replaced on a documented schedule. It is not a substitute for soft splint formulations, denture base acrylics, surgical guide resins, or castable resins.