# K221450: Phosphoric Acid Etching Gel

- Pathway: 510(k) (Traditional)
- Applicant: Rizhao Huge Biomaterials Company, Ltd.
- Decided: Sep 12, 2022 after 117 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: 2 generations back to K923842 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101485: All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch- 37 with Bac; Dark- Etch, Dark Etch (Blue- E, Bisco, Inc. (2010) Summary page 4.

## Indications for use
Used for etching of tooth enamel and/or dentin prior to the applications of bonding direct filling, repairing or enamel surface coating materials, as well as cementation of indirect restorations such as crowns, bridges, inlays/onlays, veneers, posts, splints, orthodontic brackets, etc. made of resin composites, porcelains/ceramics, metals and their combinations. Can also be used for cleaning of restoration surfaces prior to repairing or cementation.

Source page: https://510kreport.com/device/K221450
Methodology: https://510kreport.com/methodology