FDA · official record K072754Substantially Equivalent

AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE

Name: AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE — FDA K072754
Creator: Axenic Dental, Inc.
Keywords: AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE, AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE, K072754, EFB, FDA

United StatesEFBAxenic Dental, Inc.

Verified

Official record identity

FDA application number: K072754
Decision date: January 25, 2008
Published decision: Substantially Equivalent

Classification

Product code: EFB

Published parties

Applicant: Axenic Dental, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2007-09-27
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4200

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.