# K964285: Tetric Ceram

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: Jan 22, 1997 after 86 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K994268: Arabesk Top (2000), 1 descendant of its own
- K063604: Twinky Star NF (2007), 0 descendants of its own
- K033996: Hermes (2004), 0 descendants of its own
- K994304: Arabesk Flow (2000), 0 descendants of its own
- K982692: Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LC (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K964285
Methodology: https://510kreport.com/methodology