# K102973: Silver Dental Arrest

- Pathway: 510(k) (Traditional)
- Applicant: Cooley Consulting, Inc.
- Decided: Jul 31, 2014 after 1,394 days
- Product code: PHR (Diammine Silver Fluoride Dental Hypersensitivity Varnish)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 6 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K241041: Silver Fluoride Hypersensitivity Varnish (2025), 0 descendants of its own
- K240059: FAgamin® (2024), 0 descendants of its own
- K240619: e-SDF (2024), 0 descendants of its own
- K222459: Centrix FluoroSilver Silver Diamine Fluoride 38% (2023), 0 descendants of its own
- K222323: Black Diamond (2023), 0 descendants of its own

## Indications for use
Treatment of Dental Hypersensitivity. For use in adults over the age of 21.

Source page: https://510kreport.com/device/K102973
Methodology: https://510kreport.com/methodology