FDA · official record K070196Substantially Equivalent

FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT

Name: FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT — FDA K070196
Creator: Hr Dental Products, Inc.
Keywords: FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT, FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT, K070196, EIA, FDA

United StatesEIAHr Dental Products, Inc.

Verified

Official record identity

FDA application number: K070196
Decision date: January 26, 2007
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: Hr Dental Products, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2007-01-22
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6640

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.