FDA · official record K240888Substantially Equivalent

Calibra Abutment Resin Cement

Name: Calibra Abutment Resin Cement — FDA K240888
Creator: Dentsply Sirona
Keywords: Calibra Abutment Resin Cement, Calibra Abutment Resin Cement, K240888, EMA, FDA

United StatesEMADentsply Sirona

Verified

Official record identity

FDA application number: K240888
Decision date: April 02, 2024
Published decision: Substantially Equivalent

Classification

Product code: EMA

Published parties

Applicant: Dentsply Sirona

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2024-04-01
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3275

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.