# K970495: Foundation Indirect Composite Resin

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Apr 16, 1997 after 65 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: 1 generation back to K955331 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955331: Belleglashp, Sybron Dental Specialties, Inc. (1996) Summary page 1.
- (no number) Concept: named in the summary without a submission number
- (no number) Art Glass: named in the summary without a submission number

Source page: https://510kreport.com/device/K970495
Methodology: https://510kreport.com/methodology