# K200462: EtchPro Etching Gel

- Pathway: 510(k) (Traditional)
- Applicant: Belport Company, Inc., Gingi-Pak
- Decided: Sep 2, 2020 after 190 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 K031915 (2003). 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)
- K031915: Pulpdent Etch-Rite Royale, Pulpdent Corporation (2003) Summary page 4.

## Indications for use
EtchPro® Etching Gel is intended to be used by dental professionals to etch the dentin and enamel before tooth restoration treatments.

Source page: https://510kreport.com/device/K200462
Methodology: https://510kreport.com/methodology