# K070289: Acquaseal Benz

- Pathway: 510(k) (Traditional)
- Applicant: Acquamed Technologies, Inc.
- Decided: May 4, 2007 after 94 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 K953405 (1995). 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)
- K953405: Hema-Benz, Health-Dent Intl., Inc. (1995) Summary page 1.

## Indications for use
The Acquaseal Benz is indicated for dental restorative, hypersensitivity, cervical, and hygiene procedures.

Source page: https://510kreport.com/device/K070289
Methodology: https://510kreport.com/methodology