# K012517: CEREC3 Vitablocks

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Nov 1, 2001 after 87 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
Longest line of descent: 1 generation back to K994172 (2000). 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)
- K994172: CEREC 3, Sirona Dental Systems GmbH (2000) Summary page 1.

## Indications for use
The CEREC® inLab and CEREC® Scan Dental Restoration Milling Machines are intended to be used in the computer-aided design and milling of ceramic dental restorations, including inlays, onlays, veneers, crowns (full and partial), crown caps and bridge frameworks.

Source page: https://510kreport.com/device/K012517
Methodology: https://510kreport.com/methodology