FDA · official record K092341Substantially Equivalent

LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION

Name: LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION — FDA K092341
Creator: Biomet 3i, Inc.
Keywords: LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION, LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION, K092341, NHA, FDA

United StatesNHABiomet 3i, Inc.

Verified

Official record identity

FDA application number: K092341
Decision date: November 30, 2009
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Biomet 3i, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2009-08-04
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.