# K012436: Modification to Alloy Primer

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 4, 2001 after 35 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). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 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.

## Most influential descendants
- K171226: Tokuyama Universal Bond (2017), 1 descendant of its own
- K203760: Tokuyama Universal Bond II (2021), 0 descendants of its own

## Indications for use
ALLOY PRIMER is indicated for the following applications: 1) Adhesion of metal posts, metal inlays, onlays, crown and bridges 2) Repair of fractures resin-based facing crowns and porcelain-fused metal crowns 3) Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures

Source page: https://510kreport.com/device/K012436
Methodology: https://510kreport.com/methodology