# K022975: Etching 15

- Pathway: 510(k) (Traditional)
- Applicant: Ab Ardent
- Decided: Nov 22, 2002 after 77 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
ETCHING 15 is used in the enamel or total etch techniques for Composite restorations Adhesive cementation of inlays (composite and ceramic) crowns, bridges, veneers, adhesive bridges and root posts. Splints Bonding of orthodontic attachments Fissure sealings

Source page: https://510kreport.com/device/K022975
Methodology: https://510kreport.com/methodology