# K964179: Super-Dent Etching Gel, Super-Dent Micro-Etch Gel and Super-Dent Etching Gel Syringe Tips

- Pathway: 510(k) (Traditional)
- Applicant: S.S. White Mfg., Ltd.
- Decided: Jan 9, 1997 after 83 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 2.

## Indications for use
These materials are intended for use in preparation of tooth material prior to restoration by etching of the surface.

Source page: https://510kreport.com/device/K964179
Methodology: https://510kreport.com/methodology