# K120243: GAM-200

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jun 27, 2012 after 152 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K073209 (2008). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073283: GC GAM-100, GC America, Inc. (2008) Summary page 1.
- K073209: Maxcem 2, Kerr Corporation (2008) Summary page 1.

## Most influential descendants
- K214076: EsCem (2022), 0 descendants of its own

## Indications for use
1. Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges. 2. Cementation of metal, ceramic, fiber posts, and cast post and cores.

Source page: https://510kreport.com/device/K120243
Methodology: https://510kreport.com/methodology