# K242462: CEREC Cercon 4D CAD/CAM Blocks

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Oct 24, 2024 after 66 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: 2 generations back to K060104 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123545: Incoris Tzi, Sirona Dental Systems GmbH (2013) Summary page 5.
- K190436: KATANA Zirconia Block, Kuraray Noritake Dental, Inc. (2019) Summary page 5.

## Indications for use
Indications for CEREC Cercon 4D CAD/CAM Blocks are: -Crowns and bridges in the posterior and anterior tooth region - Bridges with a maximum of two pontics - Inlays, onlays and veneers

Source page: https://510kreport.com/device/K242462
Methodology: https://510kreport.com/methodology