# K222323: Black Diamond

- Pathway: 510(k) (Traditional)
- Applicant: Elevate Oral Care, LLC
- Decided: Jun 23, 2023 after 325 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
Longest line of descent: 1 generation back to K102973 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102973: Silver Dental Arrest, Cooley Consulting, Inc. (2014) Summary page 4.

## Indications for use
Black Diamond is intended as Treatment of Dental Hypersensitivity. For use in adults over the age of 21.

Source page: https://510kreport.com/device/K222323
Methodology: https://510kreport.com/methodology