Renamel Bulkfill

K211259 · Cosmedent, Inc. · EBF · Jun 24, 2021 · Dental

Device Facts

• Record ID: K211259
• Device Name: Renamel Bulkfill
• Applicant: Cosmedent, Inc.
• Product Code: EBF · Dental
• Decision Date: Jun 24, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

1. Direct Posterior Restorations (including occlusal surfaces) 2. Replacement of individual cusps 3. Base-liner under direct restorations. 4. Restorations of deciduous teeth 5. Class V restorations (cervical caries, root erosion, wedge-shaped defects)

Device Story

Renamel Bulkfill is a light-cured, resin-based dental restorative material. It is used by dental professionals in a clinical setting to restore tooth structure. The material is placed into the prepared tooth cavity and cured using a dental curing light. It functions as a restorative material for posterior teeth, including occlusal surfaces, cusp replacement, and Class V restorations, or as a base-liner under other direct restorations. It provides a restorative solution for both permanent and deciduous teeth, helping to restore form and function to damaged or decayed teeth.

Clinical Evidence

bench testing only

Technological Characteristics

Light-cured, resin-based dental restorative material. Class II device (21 CFR 872.3690).

Indications for Use

Indicated for patients requiring direct posterior restorations, cusp replacement, base-liner application, deciduous tooth restoration, or Class V restorations (cervical caries, root erosion, wedge-shaped defects).

Regulatory Classification

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.

Submission Summary (Full Text)

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June 24, 2021

Cosmedent, Inc Gary Chuven Director of Regulatory Affairs 401 N Michigan Ave, Suite 2500 Chicago, Illinois 60611

Re: K211259

Trade/Device Name: Renamel Bulkfill Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: April 22, 2021 Received: April 29, 2021

## Dear Gary Chuven:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 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 ([e-mail]) or phone [phone] 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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## Section 4: Indications for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|----------------------------------|
| Food and Drug Administration | Expiration Date: 06/30/2023 |
| Indications for Use | See PRA Statement below. |

| 0(k) Number (if known) | |
|------------------------|--|
|------------------------|--|

510 K211259

Device Name Renamel Bulkfill

Indications for Use (Describe)

1. Direct Posterior Restorations (including occlusal surfaces)

2. Replacement of individual cusps

3. Base-liner under direct restorations.

4. Restorations of deciduous teeth

5. Class V restorations (cervical caries, root erosion, wedge-shaped defects)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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