| Код ТН ВЭД | 802333 |
Как аккредитованный завод Proto3000 Formlabs Dental LT Comfort Resin V1.1, мы соблюдаем строгие протоколы качества - каждая партия подвергается строгим испытаниям для обеспечения последовательных стандартов эффективности и безопасности.
| Упаковка | Single 1 L cartridge of Proto3000 Formlabs Dental LT Comfort Resin V1.1, sealed in foil pouch with labels. |
| Погрузка контейнера (20-футовый контейнер) | 20′ FCL container loading of chemical Proto3000 Formlabs Dental LT Comfort Resin V1.1; palletized, braced, secured for safe ocean transport. |
| Доставка | Proto3000 Formlabs Dental LT Comfort Resin V1.1 is typically not classified as dangerous goods for transport and ships in sealed, light-resistant original containers via standard carrier services. Store upright, away from heat, sunlight, and ignition sources. Handle as a potential skin sensitizer; follow the SDS and carrier/local regulations. |
| Хранение | Store Proto3000 Formlabs Dental LT Comfort Resin V1.1 in its original, tightly closed, upright container in a cool, dry, well-ventilated area. Protect from direct sunlight, UV light, heat, sparks, and flames. Keep at recommended room temperature; do not freeze. Segregate from oxidizers, polymerization initiators, food, and drink. Keep containers closed when not in use, and follow the SDS and local regulations. |
| Срок годности | Shelf life is 12 months from date of manufacture when stored unopened at 18–28°C, away from direct sunlight and heat. |
Printed maxillary flat-plane guards for electromyographically confirmed sleep bruxism are produced as full-arch occlusal stabilization devices with a flat occlusal table and a minimum functional thickness of 1.5 mm across the cusp tips. The resin is used as supplied; dilution with isopropyl alcohol, methyl methacrylate monomer, or low-viscosity aliphatic urethane acrylate is incompatible with the free-radical photopolymerization and depresses crosslink density below the threshold required for prolonged mucosal contact. On a Formlabs Form 3B or Form 3BL station operating at 405 nm with a 100 μm layer height, build orientation is set to 30–35° from vertical, and support touchpoints are confined to the polished buccal and labial surfaces at a spacing of 1.2 mm; occlusal support placement is prohibited because residual nibs create premature contacts that require chairside adjustment and disrupt the flat plane. After printing, the guard is washed in a Form Wash with 95–99 % isopropyl alcohol for 10 minutes at 25 °C, dried with oil-free compressed air until a haze-free surface is obtained, and post-cured in a Form Cure at 60 °C for 30 minutes. A post-cure interval below 20 minutes leaves unreacted methacrylate groups that elevate leachables beyond the level established for surface-contacting oral devices under ISO 10993-1:2018, Clause 5.3; a post-cure temperature above 70 °C initiates thermal yellowing and may warp thin occlusal tables. Biological evaluation for this appliance class is anchored to ISO 10993-5:2009 using quantitative MTT cytotoxicity on polymer extracts and to ISO 10993-10:2010 for oral mucosal irritation, with the resin categorized as a surface-contacting medical device with prolonged mucosal exposure. The terminal product is a clear flat-plane maxillary night guard that is adjusted on the master cast with 8 μm red articulating foil and polished with a felt wheel and pumice slurry at a surface temperature below 45 °C; silicone polishing pastes are preferred over methyl methacrylate-based glaze to avoid surface swelling.
In high-force bruxism patients with masseter hypertrophy, an anterior bite plane is designed with a raised incisal platform angled 15° relative to the occlusal plane and a posterior disclusion of 0.5 mm measured at the second molar. The print workflow for this geometry uses a 100 μm layer height and orients the incisal platform away from the build platform; support pillars of 0.8 mm diameter are placed along the facial cervical third at a touchpoint density of 1.0 mm⁻¹ rather than on the lingual incline, because lingual support nibs cannot be polished without changing the guidance slope. The resin is processed neat, but working viscosity must be verified at 25 °C before each build; a cartridge stored below 15 °C must be warmed to room temperature for 3 hours and homogenized by gentle inversion, otherwise recoating defects appear at thin incisal edges. Washing is performed in two successive 5-minute isopropyl alcohol baths at 25 °C, with the first bath saturated after six full build plates; the second bath is used until turbidity exceeds 0.1 % by volume of suspended oligomer. Post-curing at 60 °C for 30 minutes is followed by seating on the trimmed master cast; selective reduction of the incisal platform is performed with a slow-speed handpiece and a carbide bur, and no more than 0.4 mm of reduction is permitted before verifying posterior disclusion with 8 μm foil. Compliance for this anterior repositioning device includes ISO 10993-1:2018, Clause 5.2, for biological evaluation planning, ISO 10993-5:2009 for extract cytotoxicity, and ISO 10993-10:2010 for delayed-type sensitization and oral mucosal irritation; the device is not intended for patients with an anterior open bite or for mandibular advancement beyond 3 mm. The terminal product is a maxillary anterior bite plane with canine guidance, polished on all tissue-bearing aspects and left with a matte occlusal platform for chairside adjustment.
Full-arch stabilization splints prescribed for arthrogenous TMD are generated from a centric relation bite registration, not from maximum intercuspation, and are designed with bilateral occlusal contacts at a total posterior thickness of 0.5–1.0 mm over the cusp tips. The build uses a 50 μm layer height on a Formlabs Form 3BL to reduce staircase artifacts on the occlusal fossae; support anchors are placed on the buccal vestibular surface with a spacing of 1.5 mm, and the occlusal surface is oriented at 45° to the build platform to avoid a planar cross-section that would generate large peel-force zones. Resin viscosity is monitored at 25 °C with a cone-and-plate viscometer at 10 s⁻¹ before each fill; deviation above 15 % from the manufacturer’s certificate of analysis indicates moisture uptake or partial polymerization and requires cartridge rejection. The splint is allowed to rest at 23 °C and 50 % relative humidity for 1 hour between washing and post-cure, which reduces solvent-induced microcrazing on the thick centric relation stops; the resin is not diluted, and attempts to lower viscosity with 1–2 % isopropyl alcohol before printing produce undercured interlayer regions outside the validated workflow. Post-curing at 60 °C for 30 minutes is performed with the splint supported on a customized silicone jig, not on a flat glass tray, because unsupported posterior extensions undergo creep under elevated temperatures. Mechanical conformity is checked against ISO 178:2019 three-point flexural specimens printed in the same batch; batch-to-batch flexural modulus deviation above 15 % from the release value triggers full revalidation. Water sorption is assessed by immersion at 37 °C for 7 days according to the gravimetric method of ASTM D570-98; published data for this specific resin grade are limited, but an increase above 2.0 % by mass would invalidate the splint because occlusal contact positions shift by more than 0.1 mm after overnight saliva exposure. The terminal product is a hard full-arch stabilization splint with bilateral balanced occlusion, delivered with a written adjustment schedule and no resilient lining.
For post-orthodontic retention after fixed appliance debonding, the clear overlay retainer is printed at a 50 μm layer height, with the digital model offset 0.05 mm on the facial aspect to produce a passive fit and the occlusal table held between 0.75 mm and 1.0 mm. Undercut engagement is limited to 0.25 mm below the height of contour; greater engagement increases insertion stress at the mesial canine and can propagate cracks along the gingival margin. The build is oriented with the occlusal plane vertical and the lingual surface facing the build platform, because this orientation places support projections in the non-visible intaglio region where they are removed with a scalpel and a 600-grit silicone wheel. Washing uses two 5-minute isopropyl alcohol stages: the first is 99 % anhydrous alcohol, and the second is a clean 99 % bath to remove residual oligomer film; 70 % alcohol is unsuitable because water ingress swells the thin retainer surface and causes white haze after curing. Post-curing is carried out at 60 °C for 20 minutes when the shell is below 1.0 mm, because longer exposure does not increase degree of conversion but raises water sorption and reduces fracture toughness under repeated insertion and removal cycles. Compliance for this long-term orthodontic appliance references ISO 20795-2:2013 for orthodontic base polymers, ISO 10993-5:2009 for cytotoxicity of extracts, and ISO 10993-10:2010 for delayed-type sensitization. The retainer must not be placed in an ultrasonic bath with water above 40 °C; thermal deformation of the palatal vault exceeds 0.2 mm at 50 °C. The terminal product is a clear overlay retainer with a labial window free of support marks and a smooth, polished gingival margin.
A hard outer shell printed from Dental LT Comfort Resin V1.1 is designed with a 2.0 mm recess on the intaglio surface for a chairside resilient liner, protecting implant-supported fixed prostheses during parafunctional activity. The digital design leaves 0.3 mm of rigid occlusal coverage over the opposing dentition and maintains 1.5 mm of bracing wall on the buccal and lingual flanges. The shell is printed intaglio-up to eliminate support marks in the reline cavity; supports are placed on the polished external surface at 0.8 mm spacing, and the material is used as supplied without adding plasticizer. After printing, the shell is washed in 99 % isopropyl alcohol for 10 minutes and air-dried for 45 minutes before post-cure; residual alcohol inside the recess causes bubbles and poor liner adhesion when the chairside reline material is packed. Post-curing at 60 °C for 30 minutes is followed by application of a primer to the recess and packing with a tissue-conditioning reline material; the reline thickness must not exceed 2.5 mm, or the rigid walls flex and the shell loses occlusal coverage. Compliance for the printed shell itself follows ISO 10993-1:2018 for prolonged mucosal contact and ISO 10993-5:2009 for extract cytotoxicity; the chairside reline material must be evaluated separately under ISO 10139-2:2016 for denture soft lining materials. The terminal product is an implant-protection occlusal guard with a hard printed shell and a resilient intaglio liner, delivered only after verifying that the liner cuff terminates 2.0 mm away from the implant emergence profile.
In paediatric bruxism cases with mixed dentition, the printed guard includes 4.0 mm eruption windows around partially erupted first permanent molars and 0.5 mm clearance at the gingival margin to avoid pressure on the pericoronal operculum. The appliance is designed with a 2.0 mm posterior occlusal table and 1.5 mm anterior coverage; the resin is processed at 100 μm layer height with supports placed on the facial surface opposite the eruption windows, and support tips are set to 0.6 mm diameter to reduce breakage during support removal from thin margins. Washing and post-cure follow the standard 60 °C for 30 minutes protocol, but the guard is bench-cooled inside the Form Cure for 10 minutes before extraction to prevent warping of the narrow eruption bridges. Heat-cured ethylene-vinyl acetate liner sheets are not used with this resin because differential thermal expansion at the interface can produce delamination; published cycling data for this specific combination are limited. Biological evaluation for the paediatric device is governed by ISO 10993-1:2018 with attention to leachables in a simulated saliva extract at 37 °C for 72 hours, supported by toxicological risk assessment under ISO 10993-17:2023, and ISO 10993-10:2010 for oral mucosal irritation; the guard is not indicated for children younger than 6 years without a separate airway assessment. The terminal product is a mixed-dentition night guard with eruption slots that is re-evaluated every 3 months for fit changes during active tooth eruption.
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Proto3000 Formlabs Dental LT Comfort Resin V1.1 is a light-curable methacrylate photopolymer supplied in a 1 L cartridge for Formlabs Form 3B and Form 3B+ low-force stereolithography printers. The resin is indicated for the direct additive manufacturing of long-term occlusal splints, night guards, and mandibular repositioning appliances. The PreForm software includes a resin-specific profile that governs laser power, layer thickness, support contact geometry, and build platform adhesion. Manufacturer documentation positions the material as a low-modulus, high-elongation alternative to rigid splint resins; the intended service environment is removable long-term intraoral use, not permanent restorative or implant applications. Biological evaluation follows ISO 10993-1:2018 as a long-term mucosal contact material, with cytotoxicity and irritation/sensitization testing referenced in the technical data sheet. The product is differentiated from Formlabs Dental LT Clear V2 by lower stiffness and higher flexibility, which alters clinical load distribution and laboratory finishing behavior. No additive or coating should be introduced without verifying that the final appliance remains within the manufacturer’s stated indications and biocompatibility documentation.
Before printing, the cartridge is conditioned to 10–25 °C. Resin viscosity increases below 20 °C, extending recoating time and increasing the probability of thin-layer defects on the occlusal surface. The Form 3B/Form 3B+ cartridge bay maintains the resin within the validated temperature window under normal laboratory conditions; placement near HVAC diffusers, exterior windows, or heat-generating equipment can introduce local thermal drift. PreForm settings for Dental LT Comfort Resin V1.1 are resin-specific and should not be manually overwritten unless the workflow has been revalidated against the current technical data sheet. After the build, parts are removed from the platform and washed in ≥99% isopropyl alcohol or an equivalent solvent identified in the resin usage instructions. Post-curing is performed in Form Cure at 60 °C for 30 min, unless the current V1.1 instructions revise the duration. In continuous dental laboratory production, the principal process bottleneck occurs after washing; residual alcohol trapped in occlusal grooves and splint channels plasticizes the polymer surface and depresses hardness readings obtained under ASTM D2240-15. Premature detachment of warm parts from the build platform is another observed failure mode because the low-modulus network may warp at thin border regions if the platform has not cooled to ambient temperature.
Mechanical characterization for this resin family is expressed under ASTM D638-14, ASTM D790-17, and ASTM D2240-15. Published data for Dental LT Comfort Resin V1.1 specifically are limited; comparative values for the LT Comfort family and Dental LT Clear V2 are available in current Formlabs dental materials documentation. The material is designated as a low-modulus resin, meaning flexural modulus and tensile strength are reduced relative to rigid splint resins, while elongation at break is higher. This property balance reduces stress concentration at cusp tips and incisal edges but requires adequate wall thickness in high-load regions.
| Parameter | Configuration | Standard/Reference |
|---|---|---|
| Cartridge volume | 1 L | Formlabs cartridge format |
| Validated printer platforms | Form 3B, Form 3B+ | PreForm resin-specific profile |
| Wash solvent | ≥99% isopropyl alcohol or equivalent | Form Wash usage instructions |
| Post-cure temperature | 60 °C | Form Cure resin profile |
| Post-cure duration | 30 min | Form Cure resin profile |
| Storage temperature | 10–25 °C | Manufacturer technical data sheet |
| Biocompatibility evaluation | Long-term mucosal contact | ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010 |
Compared with Dental LT Clear V2, which is a rigid high-clarity splint material, V1.1 trades tensile strength and hardness for flexural compliance and patient comfort. The lower modulus allows the splint to flex under occlusal force, distributing stress across the dentition; however, occlusal stability may require a thicker design in patients with severe bruxism. Published independent wear-rate comparisons between V1.1 and Dental LT Clear V2 are limited. Selection between the two materials should therefore be based on the clinical force environment, laboratory post-processing capacity, and the patient-specific need for rigidity versus compliance.
Dimensional accuracy and occlusal fit are controlled by the combination of printer calibration, build orientation, and post-cure shrinkage. In splint production, the occlusal plane is typically oriented away from the build platform with support contacts placed on non-functional surfaces. Form 3B/Form 3B+ build engines produce a continuous laser-generated interface; the resin’s low modulus reduces brittle fracture during support removal but can increase the risk of tearing thin interproximal walls if supports are removed too aggressively. After post-curing, the printed appliance is finished with dental acrylic burs, rubber points, and low-speed polishing wheels. If the polishing protocol generates heat above 60 °C, local surface softening may occur; intermittent pressure and water irrigation are used to control temperature. Laboratories should record resin lot codes and printer serial numbers because batch-to-batch viscosity variation and laser calibration interact to affect surface finish. The use of an in-house fixed measuring protocol—checking total thickness at occlusal contact areas with a dental thickness gauge before and after polishing—is a practical method to detect over-polishing in low-modulus resin.
When the appliance is designed for long-term intraoral service, the laboratory must retain the manufacturer’s biocompatibility documentation and ensure that no non-validated solvents, coatings, or adhesives are introduced. Formlabs supplies declarations referencing ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 for the Dental LT Comfort family; these address cytotoxicity, irritation, and sensitization under long-term mucosal contact. The V1.1 formulation is not indicated for permanent implantation, osseous contact, or direct restorative use. Residual monomer is minimized by complete washing and by adhering to the specified post-cure temperature and duration. Production laboratories commonly implement inspection of internal lumens and occlusal indentations after washing, because uncured resin trapped in anatomical details is a known cause of patient-contact complaints and remake costs. The final appliance should be polished with compounds approved for dental acrylics; pumice-free systems reduce the risk of embedding abrasive particles in the low-modulus surface.
Autoclave and dry-heat sterilization are not recommended for Dental LT Comfort Resin V1.1 because the low-modulus methacrylate network softens at elevated temperatures and may deform under load. High-pH detergents, amine-containing disinfectants, and chlorinated solvents are incompatible; they can induce stress cracking, surface haze, or localized swelling. Shelf life is stated on the cartridge label and is typically 12 months from the date of manufacture when stored at 10–25 °C in the unopened cartridge. Cartridges must be shielded from direct sunlight and strong UV-emitting fluorescent sources. Frozen storage is not permitted; phase separation or premature gelation may occur below the specified lower bound. In multi-resin laboratories, cross-contamination of the resin tank, build platform, and wash solvent must be prevented. Residual traces of high-modulus resins on the build platform can alter first-layer adhesion and cause delamination of low-modulus splint borders. Similarly, wash solvent contaminated with other monomers can affect surface cure and final mechanical properties. The operational boundary for solvent reuse is defined by the Form Wash instructions and the solvent supplier; exhausted solvent produces tacky surfaces that cannot be fully resolved by extended post-curing.
For regulatory documentation, material safety data and current compliance statements should be retrieved from the Proto3000 and Formlabs product pages before clinical use. The resin is intended for use by dental professionals and dental laboratories; non-dental applications are outside the documented service envelope. When the printed appliance is delivered, the laboratory should provide the prescribing clinician with lot code information, post-curing confirmation, and applicable compliance references. Published data for this specific configuration is limited for certain wear and long-term color stability endpoints; verification under representative intraoral conditions remains the responsibility of the dental professional.