# K972594: Metalprimer II

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Aug 26, 1997 after 46 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Metalprimer |l is a metal surface treatment material which provides a bond between the resin and metal in fabriacting dental appliances such as bonding opaque material to metal framework for hard resin veneer crowns, bonding denture base resin to metal base, clasp, attachment, repair of denture and bonding orthodontic resin to metal orthodontic bracket and wire.

Source page: https://510kreport.com/device/K972594
Methodology: https://510kreport.com/methodology