# K091300: Ascent Porcelain Primer, Model 006-00078, 00600079

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Jul 23, 2009 after 80 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). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061322: Porcelain Primer, J. Morita USA, Inc. (2006) Summary page 1.
- K061906: Clearfil Ceramic Primer, Kuraray Medical, Inc. (2006) Summary page 1.
- K951582: Ultradent Porcelain Etch, Ultradent Products, Inc. (1995) Summary page 1.

## Indications for use
Ascent Prep Porcelain Primer is indicated for the conditioning of porcelain dental appliances prior to the placement or adhesion of said porcelain to tooth structures within the oral cavity, resin based tooth restorative materials, or to other porcelain oral appliances.

Source page: https://510kreport.com/device/K091300
Methodology: https://510kreport.com/methodology