← Product Code MQC · K222061 # Dental LT Clear V2 Resin (K222061) _Formlabs Ohio, Inc. · MQC · Nov 10, 2022 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K222061 ## Device Facts - **Applicant:** Formlabs Ohio, Inc. - **Product Code:** MQC - **Decision Date:** Nov 10, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use Dental Clear LT V2 Resin when utilized to print dental or orthodontic appliances such as occlusal splints, night guards, or mouth guards is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively. ## Device Story Dental LT Clear V2 Resin is a light-curable, polymer-based resin for additive manufacturing of biocompatible, long-term use, removable dental and orthodontic appliances. Used by dental professionals to fabricate custom occlusal splints, night guards, and mouth guards for patients with TMD or Bruxism. Material is processed via 3D printing; cured to form final appliance. Provides mechanical support and protection for teeth/jaw. Biocompatible for long-term (>30 day) mucosal contact. ## Clinical Evidence Bench testing only. Performance evaluated against ASTM D790-17 (flexural modulus), ASTM D638-14 (tensile strength/elongation), ASTM D2240-15 (hardness), and ISO 20795-2 (water sorption/solubility). Biocompatibility testing performed per ISO 10993-1:2018 and ISO 7405:2018, covering cytotoxicity, sensitization, systemic toxicity, and genotoxicity. ## Technological Characteristics Light-curable polymer-based resin. Additive manufacturing (3D printing). Mechanical properties: Flexural modulus ≥ 2000 MPa (ASTM D790-17), Ultimate tensile strength ≥ 50 MPa (ASTM D638-14), Elongation ≥ 10% (ASTM D638-14), Hardness 78D (ASTM D2240-15). Biocompatible for long-term mucosal contact. ## Predicate Devices - KeyPrint® KeySplint Hard™ ([K203000](/device/K203000.md)) - KeyPrint® KeySplint Soft™ ([K183598](/device/K183598.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 10, 2022 Formlabs Ohio, Inc. Ritika Sharma Regulatory Affairs Specialist 27800 Lemoyne Rd Millbury, Ohio 43447 Re: K222061 Trade/Device Name: Dental LT Clear V2 Resin Regulatory Class: Unclassified Product Code: MQC, KMY, DYT Dated: August 11, 2022 Received: August 15, 2022 Dear Ritika Sharma: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Michael E. Adjodha -S Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222061 Device Name Dental LT Clear V2 Resin Indications for Use (Describe) Dental Clear LT V2 Resin when utilized to print dental or orthodontic appliances such as occlusal splints, night guards, or mouth guards is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------|----------------------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | --- # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Formlabs. The word "formlabs" is written in a sans-serif font in blue. To the right of the word is a stylized blue icon that appears to be a geometric representation of a butterfly or a stylized "f". #### 510(K) SUMMARY 1. Submitter's Name: Formlabs Ohio Inc. 2. Address: 27800 Lemoyne Rd Millbury, OH 43447 USA #### 3. Contact Person Ritika Sharma Regulatory Affairs Specialist Phone Number: 323-781-9504 Email: ritika.sharma@formlabs.com #### 4. Date Prepared: November 8, 2022 5. Trade Name: Dental LT Clear V2 Resin # 6. Common Name: Dental LT Clear V2 Resin #### 7. 510(k) Number: K222061 #### 8. Product Classification and Regulations: Primary Product Code: MQC (Mouthguard, Prescription) Regulation: Not subject to a Part 800 classification regulation Risk Class- Unclassified Secondary Product Codes: KMY (Positioner, Tooth, Preformed), DYT (Maintainer, Space Preformed, Orthodontic) Panel: Dental #### 9. Predicate Devices: Primary Predicate Device: KeyPrint® KeySplint Hard™ (K203000) Secondary Predicate Device: KeyPrint® KeySplint Soft™ (K183598) {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "formlabs" in blue font, followed by a blue abstract logo. The logo is composed of several lines that form a geometric shape. The logo is located to the right of the word "formlabs". # 10. Description of Device: Dental LT Clear V2 Resin is a light-curable polymer-based resin designed for the fabrication of biocompatible, long-term use, removable dental and orthodontic appliances by additive manufacturing. ## 11. Indication for Use: Dental Clear LT V2 Resin when utilized to print dental or orthodontic appliances such as occlusal splints, night guards, or mouth guards is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively. ## 12. Summary of the non-clinical testing data Dental LT Clear V2 Resin meets the applicable standardized testing requirements for orthodontic materials. Table 1 summarizes the non-clinical testing data that was submitted, referenced, or relied on to demonstrate the substantial equivalence of the subject device, and whose performance meets of its predefined acceptance criteria. | Technological / Performance
Characteristic | Test Method | Acceptance Criteria | Post Cured
Results | |-----------------------------------------------|---------------|-------------------------------|-----------------------| | Flexural modulus | ASTM D790-17 | $\geq$ 1 GPa | $\geq$ 2000 MPa | | Ultimate tensile strength | ASTM D638-14 | $\geq$ 35 MPa | $\geq$ 50 MPa | | Elongation | ASTM D638-14 | $\geq$ 0.8 % | $\geq$ 10% | | Hardness Shore D | ASTM D2240-15 | Compliant to ASTM
D2240-15 | 78D | | Water Sorption | ISO 20795-2 | <32 µg/mm³ | 28 µg/mm³ | | Water Solubility | ISO 20795-2 | <5 µg/mm³ | 1 µg/mm³ | # Table 1: Summary the Non-Clinical Testing Data of Subject Device # 13. Biocompatibility: Dental LT Clear Resin (V2) has been evaluated in accordance with ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, and ISO 7405:2018, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. The endpoints evaluated included: physical and chemical information, cytotoxicity, sensitization, acute systemic toxicity, sub-acute toxicity, sub-chronic toxicity, chronic toxicity, implantation and genotoxicity. The results of an independent biological risk assessment and endpoint testing confirmed biocompatibility. Dental LT Clear V2 is considered to meet the requirements of ISO 10993-1 : 2018 and ISO 7405: 2018, for a surface device that has long term (> 30 day) contact with mucosal membrane. # 14. Substantial Equivalence: Formlabs Ohio, Inc., submits that the Dental LT Clear V2 Resin is equivalent to the identified predicate devices KeyPrint® KeySplint Hard™ (cleared in K203000) and KeyPrint® KeySplint Soft™ (cleared in K183598) in multiple facets. After an exhaustive analysis of the subject Formlabs device and the predicate devices, Formlabs proffers that Dental LT Clear V2 Resin is substantially equivalent to the predicate devices with respect to the following: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Formlabs. The word "formlabs" is written in a sans-serif font in blue. To the right of the word is a blue icon that looks like a stylized butterfly or a geometric shape with overlapping lines. - Product Code - · Indications for Use - Device Design & User Interface - Materials of Composition and Chemical Characterization - · Manufacturing Technology and Operating Principle - · Mechanical Properties and Performance Similarities - Biocompatibility - · Patient Use and Reusability - · Removability # Comparison of the Indications for Use between the subject device and predicate devices: The predicates KeyPrint® KeySplint HardTM and KeyPrint® KeySplint Soft™ are indicated for the fabrication of orthodontic and dental appliances such as mouthguards, splints, repositioners and retainers. Dental LT Clear V2 Resin is utilized to print the same appliances as the predicates i.e., an occlusal splint, mouth guard, or night guard. Formlabs provides additional information about the medical conditions in which these appliances are widely indicated for treatment purposes in our indications for use statement. ## Comparison of technological characteristics between the subject device and identified predicates: The predicate devices and the subject device have comparable physical properties of elongation (complying to ASTM D638), flexural strength and flexural modulus (complying to ASTM D790), and hardness shore D (complying to ASTM D2240). All devices meet the applicable standardized testing requirements for orthodontic materials. Notedly, the values for mechanical properties including flexural modulus, elongation and water solubility of the subject device were found to be falling in the range between the two 510(k) cleared predicates intended for similar indication for use. Dental LT Clear V2 Resin and both the predicate devices complied to ISO 20795 for testing Water sorption and values of the subject device for this testing are found to be greater than the predicate. Since the subject device along with the predicate fall between the acceptable ranges of the recognized standard, we can reasonably assume that any noted differences would not be cause for an NSE (not substantially equivalent) determination. Table 2 presents a side-by-side comparison between the subject device and the identified predicate devices. Table 2: Comparison of Technological Characteristics Between the Subject Device and Identified Predicates | Device
Characteristic | Dental LT Clear V2
Resin (Subject Device) | KeySplint Hard
(Predicate Device) | KeySplint Soft
(Secondary Predicate) | |--------------------------|----------------------------------------------|--------------------------------------|-----------------------------------------| | | | | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "formlabs" in a sans-serif font, with the word "form" in a slightly bolder font than the word "labs". To the right of the word "formlabs" is a stylized logo that appears to be a geometric shape. The text and logo are in a bright blue color. | Mechanical Properties and Performance¹ | Flexural Strength (ASTM D790): 84 MPa | Flexural Strength (ASTM D790): 100-110 MPa | Flexural Strength (ASTM D790): 44-47 MPa | |----------------------------------------|-------------------------------------------|---------------------------------------------|-----------------------------------------------| | | Flexural modulus (ASTM D790-15): 2300 MPa | Flexural Modulus (ASTM D790): 2300-2400 MPa | Flexural Modulus (ASTM D790): 1,100–1,400 MPa | | | Elongation (ASTM D638-10): 12% | Elongation at Break (ASTM D638): 9% | Elongation at Break (ASTM D638-05): > 110% | | | Hardness Shore D (ASTM D2240-15): 78D | Shore D Hardness (ASTM D2240): 89D | Shore D Hardness (ASTM D2240): 80–85 | | | Water Sorption (ISO 20795-2): 28 µg/mm3 | Water Sorption (ISO 20795-2): 18 µg/mm3 | Water Sorption (ISO 20795-2): < 18 µg/mm3 | | | Water Solubility (ISO 20795-2): 1 ug/mm3 | Water Solubility (ISO 20795-2): 0.1 ug/mm3 | Water Solubility (ISO 20795-2): < 4.8 ug/mm3 | 1 Data for predicate devices referenced from publicly available Technical Data Sheet by KeySplint # Conclusion As presented in this 510k summary, Formlabs deems its medical device Dental LT Clear V2 Resin to be substantially equivalent to the declared predicate devices and subject devices and subject device are used in the fabrication of dental appliances that are typically customized to a patient's specific needs. It is reasonable to assume that any noted differences would not be cause for an NSE (not substantially equivalent) determination. --- **Source:** [https://fda.innolitics.com/device/K222061](https://fda.innolitics.com/device/K222061) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com