(603 days)
Not Found
Not Found
No
The 510(k) summary describes a dental restorative material and does not mention any AI or ML components or functionalities.
No
The device is a restorative material used for direct and indirect restorations in dentistry, which is a structural and aesthetic treatment rather than a therapeutic one. It does not actively treat or prevent disease.
No
Explanation: The intended use states that "OptiComp is a light cured hybrid dental restorative composite material used for direct restorations... and indirect anterior restorations," indicating it is a restorative material used for treatment, not diagnosis.
No
The intended use describes a physical dental restorative material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that OptiComp is a dental restorative material used for direct and indirect restorations in the mouth. This is a therapeutic and restorative application, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health status, disease, or condition.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information about image processing, AI/ML, input imaging modality, anatomical site (in a diagnostic sense), performance studies with diagnostic metrics (like sensitivity, specificity), and training/test sets further supports that this is not a diagnostic device.
In summary, OptiComp is a dental material used for repairing and restoring teeth, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OptiComp is a light cured hybrid dental restorative composite material used for direct restorations in all classes of cavities, including veneers and incisal edge repairs, and indirect anterior restorations, including inlays, onlays, and veneers.
Product codes
EBF
Device Description
OptiComp is a light cured hybrid dental restorative composite material.
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
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
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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.
May 25, 2022
Pac-Dent, Inc. Jingtian (Tom) Peng R&d 670 Endeavor Circle Brea. California 92821
Re: K202920
Trade/Device Name: OptiComp Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: April 5, 2022 Received: April 5, 2022
Dear Jingtian (Tom) Peng:
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 medical devices and radiation-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, 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
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Indications for Use
510(k) Number (if known) K202920
Device Name OptiComp
Indications for Use (Describe)
OptiComp is a light cured hybrid dental restorative composite material used for direct restorations in all classes of cavities, including veneers and incisal edge repairs, and indirect anterior restorations, including inlays, onlays, and veneers.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Construction, Demolition, or Other Site-Clearing
One-Time Event (e.g. Concert, Festival, Sporting Event)
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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