Data / Medical devices / Diammine Silver Fluoride Dental Hypersensitivity Varnish / United States
FDA-registered makers of Diammine Silver Fluoride Dental Hypersensitivity Varnish in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Diammine Silver Fluoride Dental Hypersensitivity Varnish (product code PHR). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Diammine Silver Fluoride Dental Hypersensitivity Varnish
- Product code
- PHR
- Country
- United States
Makers of Diammine Silver Fluoride Dental Hypersensitivity Varnish in the United States
| 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 |
| 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 November 3, 2026. 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.