# K992161: Cerana

- Pathway: 510(k) (Traditional)
- Applicant: Nordiska Dental AB
- Decided: Sep 22, 1999 after 89 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
Longest line of descent: 1 generation back to K912256 (1991). 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)
- K913372: Ips Empress, Ivoclar North America, Inc. (1991) Summary page 1.
- K972648: Sonicsys Inlay, Ivoclar North America, Inc. (1997) Summary page 1.
- K912256: Precise (R) Beta Quartz Glass-Ceramic Insert, Lee Pharmaceuticals (1991) Summary page 1.

## Indications for use
CERANA is designed to be used in class I primary and secondary caries/replacement of filling; class II primary and secondary caries and replacement of filling; restoration of ceramic crowns and repair of ceramic inlays; and class IV restorations.

Source page: https://510kreport.com/device/K992161
Methodology: https://510kreport.com/methodology