# K052189: Reveneer Ceramic Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Schutz-Dental GmbH
- Decided: Oct 17, 2005 after 67 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: 2 generations back to K871636 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974089: Alloy Primer, Kuraray America, Inc. (1997) Summary page 1.
- K943165: Clearfil Photo Bond, Kuraray Company, Ltd. (1994) Summary page 1.
- K973247: Vintage Halo, Shofu Dental Corp. (1997) Summary page 1.
- K043119: Amelogen Plus, Ultradent Products, Inc. (2004) Summary page 1.

## Indications for use
ReVeneer is an intraoral and extraoral repair system for ceramic crown and bridge veneers with the following advantages: - no acid etching (neither hydrofluoric nor phosphoric acid) - safe intraoral use - extremely good bond strength - time saving - can be used universally, with all conventional ceramics - use of conventional curing lights (halogen, LED, plasma)

Source page: https://510kreport.com/device/K052189
Methodology: https://510kreport.com/methodology