LBH · Varnish, Cavity
Dental · 21 CFR 872.3260 · Class 2
Overview
| Product Code | LBH |
|---|---|
| Device Name | Varnish, Cavity |
| Regulation | 21 CFR 872.3260 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.
Classification Rationale
Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (20 of 135)
Showing 20 most recent of 135 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | Mar 18, 2026 | SESE |
| K250714 | FluoroDose Varnish | Centrix, Inc. | Nov 21, 2025 | SESE |
| K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum) | Theodent, LLC | May 27, 2025 | SESE |
| K241489 | ReminGel | Inter-Med, Inc. | Jan 8, 2025 | SESE |
| K241568 | CrystLCare PRO Biorestorative, Fluoride-Plus | GreenMark Biomedical, Inc. | Jan 2, 2025 | SESE |
| K242913 | Jasmate® Toothpaste | Jasberry Healthcare Private Limited | Nov 22, 2024 | SESE |
| K233768 | Papacarie Duo | Elevate Oral Care | Jul 18, 2024 | SESE |
| K231060 | ProMin Dental Desensitizing Gel | Belport Company, Inc., Gingi-Pak | Jun 13, 2024 | SESE |
| K230333 | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) | Kettenbach GmbH & Co. KG | Jul 24, 2023 | SESE |
| K222891 | Dental Desensitizer | Guangzhou Beogene Biotech Co., Ltd. | May 25, 2023 | SESE |
| K231338 | 3M Clinpro Clear 2.1% Sodium Fluoride Treatment | 3M Espe Dental Products | May 10, 2023 | SESE |
| K220419 | Apapro Desensitizer | Sangi Co., Ltd. | Feb 16, 2022 | SESE |
| K200077 | BioMin Restore Plus | Dr. Collins, Inc. | Nov 6, 2020 | SESE |
| K200614 | FiteBac Antimicrobial Cavity Cleanser | Largent Health, LLC | Jun 25, 2020 | SESE |
| K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor | Scientific Pharmaceuticals | Feb 18, 2020 | SESE |
| K191453 | Cervitec F | Ivoclar Vivadent, AG | Feb 11, 2020 | SESE |
| K190271 | FiteBac Cavity Cleanser | Largent Health, LLC | Jan 23, 2020 | SESE |
| K182917 | FluoroCal | Bisco, Inc. | Nov 18, 2019 | SESE |
| K181965 | Restore Toothpaste | Dr. Collins, Inc. | Jun 13, 2019 | SESE |
| K160377 | V-varnish Premium | Vericom Co., Ltd. | Dec 2, 2016 | SESE |
Top Applicants
- Ultradent Products, Inc. — 8 clearances
- Scientific Pharmaceuticals, Inc. — 8 clearances
- Pulpdent Corp. — 7 clearances
- Novamin Technology, Inc. — 6 clearances
- Centrix, Inc. — 5 clearances
