FDA · official record K242462Substantially Equivalent

CEREC Cercon 4D CAD/CAM Blocks

Name: CEREC Cercon 4D CAD/CAM Blocks — FDA K242462
Creator: Dentsply Sirona
Keywords: CEREC Cercon 4D CAD/CAM Blocks, CEREC Cercon 4D CAD/CAM Blocks, K242462, EIH, FDA

United StatesEIHDentsply Sirona

Verified

Official record identity

FDA application number: K242462
Decision date: October 24, 2024
Published decision: Substantially Equivalent

Classification

Product code: EIH

Published parties

Applicant: Dentsply Sirona

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2024-08-19
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6660

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.