# K972648: Sonicsys Inlay

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: Oct 30, 1997 after 107 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K992161: Cerana (1999), 0 descendants of its own

## Indications for use
Tooth colored restorations for proximal cavities prepared with Sonicsys instruments (Class II in the posterior region, Class III in canines)

Source page: https://510kreport.com/device/K972648
Methodology: https://510kreport.com/methodology