# K200682: BZF-29

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Oct 2, 2020 after 200 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 K082768 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143140: G-Premio BOND, GC America, Inc. (2015) Summary page 4.

## Indications for use
BZF-29 is a two component (PRIMER and ADHESIVE), light-cured bonding agent suitable for: Bonding of light cured composites and acid modified composites (compomers) to tooth structure. Bonding of dual cured luting and core build up composites to tooth structure as long as these materials are light cured. Intraoral repairs of porcelain fused to metal crowns and composite veneer crowns with metal backing. Intraoral repairs of all ceramic crowns (except zirconia and alumina), hybrid resin jacket crowns, CAD/CAM hybrid resin crowns and composites. Intraoral repairs of porcelain fused to zirconia crowns, porcelain fused to alumina crowns and full zirconia crowns. Treatment of hypersensitive teeth.

Source page: https://510kreport.com/device/K200682
Methodology: https://510kreport.com/methodology