# K192273: DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Feb 7, 2020 after 169 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: 3 generations back to K031915 (2003). 4 ancestors in all.
1 later device descends from it; 1 cites 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)
- K112597: Seity 37% Phosphoric Acid Etchant Gel, Mycone Dental Supply Co., Inc. (2011) Summary page 4.
- K172953: Acid Etchant, American Orthodontics (2018) Summary page 4.

## Most influential descendants
- K210421: Diafil & Diafil Capsule (2021), 0 descendants of its own

## Indications for use
DiaEtch is a 37% 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/K192273
Methodology: https://510kreport.com/methodology