# K190059: CEREC Guides

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Sep 27, 2019 after 259 days
- Product code: NDP (Accessories, Implant, Dental, Endosseous)
- Device class: 1
- Regulation: 21 CFR 872.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K924630 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170849: SIMPLANT Guide, Dentsply Sirona (2017) Summary page 4.

## Indications for use
CEREC Guides are intended to support the dentist or oral surgeon when drilling for placement of dental implants. CEREC Guides are intended to be designed and fabricated using the Sirona Dental CAD/CAM System’s CEREC Chairside software and CAM equipment, Galileos Implant dental implant planning software, and Calibra Universal Self-Adhesive Resin Cement.

Source page: https://510kreport.com/device/K190059
Methodology: https://510kreport.com/methodology