# K131248: Etch Gel

- Pathway: 510(k) (Traditional)
- Applicant: Dmg America, LLC
- Decided: Jul 11, 2013 after 71 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
Longest line of descent: 1 generation back to K890464 (1989). 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)
- K890464: Zenith 40% Phosphoric Acid Gel, Foremost Dental Mfg., Inc. (1989) Summary page 1.

## Indications for use
Preparation of tooth material prior to restoration by etching of the surface.

Source page: https://510kreport.com/device/K131248
Methodology: https://510kreport.com/methodology