FDA · official record K023631Substantially Equivalent

ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS

Name: ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS — FDA K023631
Creator: Astra Tech, Inc.
Keywords: ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS, ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS, K023631, NHA, FDA

United StatesNHAAstra Tech, Inc.

Verified

Official record identity

FDA application number: K023631
Decision date: November 07, 2002
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: Special
Received date: 2002-10-29
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.