(120 days)
Not Found
No
The summary describes a resin material for 3D printing dental appliances and focuses on its material properties and performance against standardized tests. There is no mention of AI or ML.
Yes
The device is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, which constitutes a therapeutic use.
No
The device is a material (resin) used to fabricate dental appliances for treatment, not for diagnosis.
No
The device description and performance studies clearly indicate that the device is a physical resin material used for 3D printing dental appliances, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to print dental or orthodontic appliances for treating patients with TMD and/or Bruxism. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a resin for fabricating physical dental appliances. It's a material used in the creation of a medical device, not a test or assay performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on analysis of biological samples.
The information provided focuses on the physical properties and performance of the resin for creating dental appliances, which aligns with the characteristics of a medical device used for treatment.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
MQC, KMY, DYT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 | ≥ 1 GPa | ≥ 2000 MPa |
| Ultimate tensile strength | ASTM D638-14 | ≥ 35 MPa | ≥ 50 MPa |
| Elongation | ASTM D638-14 | ≥ 0.8 % | ≥ 10% |
| Hardness Shore D | ASTM D2240-15 | Compliant to ASTM D2240-15 | 78D |
| Water Sorption | ISO 20795-2 | 30 day) contact with mucosal membrane. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KeyPrint® KeySplint Hard™ (K203000), KeyPrint® KeySplint Soft™ (K183598)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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
-
Submitter's Name: Formlabs Ohio Inc.
-
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
- 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 | 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): |