# K092616: Ascent Bond Universal Adhesive System, Models 006-00029, 006-00030, 006-00044, 006-00045

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Oct 21, 2009 after 56 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: 6 generations back to K931812 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070413: Ascent Universal Adhesive, Model 006-00028, CAO Group, Inc. (2007) Summary page 1.
- K992292: Gluma Comfort Bond + Desensitizer, Heraeus Kulzer, Inc. (1999) Summary page 1.

## Indications for use
Ascent Bond Universal Adhesive System is indicated for direct bonding to and desensitizing of dentin and enamel, and direct bonding to composite, porcelain, and base metals.

Source page: https://510kreport.com/device/K092616
Methodology: https://510kreport.com/methodology