# K172953: Acid Etchant

- Pathway: 510(k) (Traditional)
- Applicant: American Orthodontics
- Decided: Feb 6, 2018 after 133 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 K031915 (2003). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152110: e-1 etchants, E Dental Products (2015) Summary page 4.

## Most influential descendants
- K192273: DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit (2020), 1 descendant of its own
- K214054: TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 (2022), 0 descendants of its own
- K210421: Diafil & Diafil Capsule (2021), 0 descendants of its own

## Indications for use
Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

Source page: https://510kreport.com/device/K172953
Methodology: https://510kreport.com/methodology