# K122522: Dentoetch Quickbond Bond Activator

- Pathway: 510(k) (Traditional)
- Applicant: Itena Clinical
- Decided: Mar 19, 2013 after 211 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: 8 generations back to K931812 (1993). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000954: Kerr Gel Etchant, Sybron Dental Specialties, Inc. (2000) Summary page 1.
- K023842: Clearfil SE Bond Plus, Kuraray Medical, Inc. (2003) Summary page 1.
- K982394: Prime & Bond NT Dual Cure Universal Dental Adhesive System, Dentsply Intl. (1998) Summary page 1.
- K964525: Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator, Dentsply Intl. (1997) Summary page 1.
- K013543: Bond-1 C & B, Jeneric/Pentron, Inc. (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K060998: QMS Tobramycin, Seradyn, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
It is intended used for etching tooth enamel and dentine when preparing surfaces for application of composites. It is intended for: Bonding composite to enamel and/or dentin; Bonding veneers, crowns & bridges, onlays and inlays Bonding composite core built-up material Bonding of composite to metal, Intraoral repairs (i.e. composite, fractured crowns & bridges, inlays & onlays and veneers); Treatment of hypersensitive teeth or exposed root surfaces; and Cavity sealing under amalgam restorations It is intended for use to enable the practitioner to use self-cure techniques for the indications where dual-cured adhesive may be desired.

Source page: https://510kreport.com/device/K122522
Methodology: https://510kreport.com/methodology