# K261246: SRGC-06

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jun 18, 2026 after 63 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K042819 (2004). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242277: Crown HT, Sprintray, Inc. (2024) Summary page 5.

## Indications for use
Individual and fixed definitive full single crowns. *Definitive partial crowns in anterior and posterior area. Individual and fixed single veneers.

Source page: https://510kreport.com/device/K261246
Methodology: https://510kreport.com/methodology