FDA · official record K022971Substantially Equivalent

MICROHYBRID 11

Name: MICROHYBRID 11 — FDA K022971
Creator: Ab Ardent
Keywords: MICROHYBRID 11, MICROHYBRID 11, K022971, EBF, FDA

United StatesEBFAb Ardent

Verified

Official record identity

FDA application number: K022971
Decision date: November 25, 2002
Published decision: Substantially Equivalent

Classification

Product code: EBF

Published parties

Applicant: Ab Ardent

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2002-09-06
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3690

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.