# K112597: Seity 37% Phosphoric Acid Etchant Gel

- Pathway: 510(k) (Traditional)
- Applicant: Mycone Dental Supply Co., Inc.
- Decided: Dec 7, 2011 after 91 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## 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
- K210421: Diafil & Diafil Capsule (2021), 0 descendants of its own
- K150696: Jade 37% Phosphoric Acid Etchant Gel (2015), 0 descendants of its own

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

Source page: https://510kreport.com/device/K112597
Methodology: https://510kreport.com/methodology