FDA · official record K981679Substantially Equivalent

TCM 3000 AND TCM ENDO

Name: TCM 3000 AND TCM ENDO — FDA K981679
Creator: NOUVAG AG
Keywords: TCM 3000 AND TCM ENDO, TCM 3000 AND TCM ENDO, K981679, EFB, FDA

United StatesEFBNOUVAG AG

Verified

Official record identity

FDA application number: K981679
Decision date: February 09, 1999
Published decision: Substantially Equivalent

Classification

Product code: EFB

Published parties

Applicant: NOUVAG AG

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1998-05-13
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.