# K993716: PA Gel 35% in Blue and PA Gel 10% in Green or Blue

- Pathway: 510(k) (Traditional)
- Applicant: Harry J. Bosworth Co.
- Decided: Dec 21, 1999 after 49 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
PA GEL 35% AND PA GEL 10% are indicated for use when etching of tooth dentin or enamel is required before bonding to the tooth structure. Ten percent concentration is indicated for either tooth dentin or enamel etching. Thirty-five percent concentration is indicated only for tooth enamel etching.

Source page: https://510kreport.com/device/K993716
Methodology: https://510kreport.com/methodology