PHR · Diammine Silver Fluoride Dental Hypersensitivity Varnish
Dental · 21 CFR 872.3260 · Class 2
Overview
| Product Code | PHR |
|---|---|
| Device Name | Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250222 | SDF Pro | Belport Company, Inc., Gingi-Pak | May 7, 2025 | SESE |
| K241041 | Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co. 1, LLC | Feb 28, 2025 | SESE |
| K240059 | FAgamin® | Tedequim Srl | May 16, 2024 | SESE |
| K240619 | e-SDF | Kids-E-Dental Llp | Mar 6, 2024 | SESE |
| K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38% | Centrix, Inc. | Oct 27, 2023 | SESE |
| K222323 | Black Diamond | Elevate Oral Care, LLC | Jun 23, 2023 | SESE |
| K172047 | Riva Star | Sdi Limited | Apr 11, 2018 | SESE |
| K102973 | SILVER DENTAL ARREST | Cooley Consulting, Inc. | Jul 31, 2014 | SESE |
Top Applicants
- Belport Company, Inc., Gingi-Pak — 1 clearance
- Centrix, Inc. — 1 clearance
- Cooley Consulting, Inc. — 1 clearance
- Elevate Oral Care, LLC — 1 clearance
- Kids-E-Dental Llp — 1 clearance
