# K082071: Adpharma Occlude and Occlude F Dentin Tubule Agent

- Pathway: 510(k) (Traditional)
- Applicant: Adpharma, Inc.
- Decided: Oct 2, 2008 after 72 days
- Product code: LBH (Varnish, Cavity)
- 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 K992629 (1999). 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)
- K992629: D/Sense II (Green-or) Dentin Desensitizer, Centrix, Inc. (1999) Summary page 1.

## Indications for use
Desensitizing agent for dentin surfaces by occluding dentin tubules to help prevent micro-leakage. Use under direct or indirect restorations following dentin etch and prior to dentin adhesive application. Desensitizing agent for use in treatment of cervical erosion in Class V restorations.

Source page: https://510kreport.com/device/K082071
Methodology: https://510kreport.com/methodology