FDA · official record K081191Substantially Equivalent

TCM ENDO 20

Name: TCM ENDO 20 — FDA K081191
Creator: NOUVAG AG
Keywords: TCM ENDO 20, TCM ENDO 20, K081191, EKX, FDA

United StatesEKXNOUVAG AG

Verified

Official record identity

FDA application number: K081191
Decision date: August 07, 2008
Published decision: Substantially Equivalent

Classification

Product code: EKX

Published parties

Applicant: NOUVAG AG

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2008-04-28
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4200

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.