# K052501: Multiple Resin Tooth Bonding Agent

- Pathway: 510(k) (Traditional)
- Applicant: Cosmedent, Inc.
- Decided: Oct 21, 2005 after 38 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910860 (1991). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910860: All-Bond 2, Bisco, Inc. (1991) Summary page 1.

## Most influential descendants
- K143694: Rhondium One-Visit-Crown (OVC) (2015), 2 descendants of its own
- K172952: Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit (2018), 0 descendants of its own
- K162677: L- OVC (2016), 0 descendants of its own

## Recalls of this device
- Sep 28, 2017 · Class II · Z-0741-2018: Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.

## Indications for use
Resin Tooth Bonding Agent is used to facilitate the adhesive bonding of restorative/preventive dental materials to dental hard tissues as well as to other restorative materials. Resin Tooth Bonding Agent is marketed as a kit that may contain: * A single light-cure resin component * A two-component self-cure resin adhesive * A phosphoric acid etchant * A silane coupling agent

Source page: https://510kreport.com/device/K052501
Methodology: https://510kreport.com/methodology