FDA · official record K083871Substantially Equivalent

ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE

Name: ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE — FDA K083871
Creator: Astra Tech, Inc.
Keywords: ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE, ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE, K083871, NHA, FDA

United StatesNHAAstra Tech, Inc.

Verified

Official record identity

FDA application number: K083871
Decision date: April 15, 2009
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Astra Tech, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2008-12-29
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.