FDA · official record K071888Substantially Equivalent

STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES

Name: STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES — FDA K071888
Creator: Straumann USA
Keywords: STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES, STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES, K071888, NHA, FDA

United StatesNHAStraumann USA

Verified

Official record identity

FDA application number: K071888
Decision date: October 15, 2007
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Straumann USA

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2007-07-09
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3630

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.