Data / Medical devices / Diammine Silver Fluoride Dental Hypersensitivity Varnish
Diammine Silver Fluoride Dental Hypersensitivity Varnish (PHR): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Diammine Silver Fluoride Dental Hypersensitivity Varnish (product code PHR, Class 2, 21 CFR 872.3260). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on May 7, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PHR
- Device class
- 2
- Regulation
- 872.3260
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| India | 1 |
| Australia | 1 |
Makers of Diammine Silver Fluoride Dental Hypersensitivity Varnish
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Centrix, Inc. | Shelton, CT, United States | Manufacturer | 1 | October 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Elevate Oral Care, LLC | West Palm Beach, FL, United States | Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 1 | July 31, 2014 | 0 | 0 | 0 | api.fda.gov |
| Kids-E-Dental LLP | Mumbai Maharashtra, India | Foreign private label distributor, Manufacturer, Specification developer | 1 | March 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Sdi Ltd. | BAYSWATER Victoria, Australia | Manufacturer | 1 | April 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Young Dental Manufacturing Co 1, LLC. | Earth City, MO, United States | Manufacturer | 1 | February 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Baron Analytical Laboratories LLC | Milford, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hexa Dental | Commerce, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Organic Consultants, LLC | Eugene, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.