# K180917: GC Acrylic Primer

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Nov 20, 2018 after 225 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: 3 generations back to K924422 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051707: Eclipse Bonding Agent, Dentsply Intl. (2005) Summary page 4.

## Indications for use
Increases the adhesiveness of light-curing composites to conventional acrylic resins used in dental laboratory procedures (e.g.,, modification of denture teeth/denture base resins)

Source page: https://510kreport.com/device/K180917
Methodology: https://510kreport.com/methodology