# K994172: CEREC 3

- Pathway: 510(k) (Special)
- Applicant: Sirona Dental Systems GmbH
- Decided: Feb 8, 2000 after 60 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K073199: 3M Espe Lava Chairside Oral Scanner (2007), 4 descendants of its own
- K081961: 3M Unitek Lava Chairside Oral Scanner (2008), 3 descendants of its own
- K122065: Digital Impression System for Orthodontic Use (2013), 1 descendant of its own
- K141611: Lythos Digital Impression System (2014), 0 descendants of its own
- K122467: 3M True Definition Scanner (2012), 0 descendants of its own

## Indications for use
The CEREC® 3 System is intended to be used in the computer-aided desigu and miuing of ceramic dental restorations, including inlays, onlays, veneers, partial crowms, and full crowns.

Source page: https://510kreport.com/device/K994172
Methodology: https://510kreport.com/methodology