FDA · official record K232487Substantially Equivalent

Provecta 3D Prime and Provecta 3D Prime Ceph

Name: Provecta 3D Prime and Provecta 3D Prime Ceph — FDA K232487
Creator: Durr Dental SE
Keywords: Provecta 3D Prime and Provecta 3D Prime Ceph, Provecta 3D Prime and Provecta 3D Prime Ceph, K232487, OAS, FDA

United StatesOASDurr Dental SE

Verified

Official record identity

FDA application number: K232487
Decision date: September 14, 2023
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Durr Dental SE

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2023-08-17
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.1750

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.