# K150696: Jade 37% Phosphoric Acid Etchant Gel

- Pathway: 510(k) (Traditional)
- Applicant: Dharma Research, Inc.
- Decided: Jun 23, 2015 after 97 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 K112597 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.

Source page: https://510kreport.com/device/K150696
Methodology: https://510kreport.com/methodology