# K973185: American Dental Products HB-35 Desensitizer with Fluoride

- Pathway: 510(k) (Traditional)
- Applicant: American Dental Products, Inc.
- Decided: Nov 14, 1997 after 81 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Use HB-35 Desensitizer with Fluoride for sensitive teeth

Source page: https://510kreport.com/device/K973185
Methodology: https://510kreport.com/methodology