# K152110: e-1 etchants

- Pathway: 510(k) (Traditional)
- Applicant: E Dental Products
- Decided: Nov 20, 2015 after 114 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.
4 later devices descend 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)
- K031915: Pulpdent Etch-Rite Royale, Pulpdent Corporation (2003) Summary page 4.

## Most influential descendants
- K172953: Acid Etchant (2018), 3 descendants of its own
- 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
Etch enamel, dentin, and glass ionomer cements

Source page: https://510kreport.com/device/K152110
Methodology: https://510kreport.com/methodology