# K193113: GC Temp Print

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jul 9, 2020 after 240 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- 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 K070991 (2007). 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)
- K180657: Resin for Temporary Crown & Bridge, Dentis Co., Ltd. (2018) Summary page 6.

## Indications for use
Fabrication of temporary crowns, bridges, inlays, onlays and veneers. Fabrication of long-term temporary restorations.

Source page: https://510kreport.com/device/K193113
Methodology: https://510kreport.com/methodology