# K972276: Cerec 2 Crown Software

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG
- Decided: Aug 15, 1997 after 58 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Cerec 2 Crown Software is a modification of the Cerec 2 Dicor Dental Restoration System. The Cerec 2 System is used to obtain an optical impression using a three-dimensional camera. The optical impression is used in the computer-aided design and milling of ceramic restorations including inlays, onlays, veneers and partial crowns. The modifications extend the capabilities to include full crowns.

Source page: https://510kreport.com/device/K972276
Methodology: https://510kreport.com/methodology