FDA · official record K070155Substantially Equivalent

INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC

Name: INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC — FDA K070155
Creator: Osseo Scientific, LLC
Keywords: INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC, INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC, K070155, EFB, FDA

United StatesEFBOsseo Scientific, LLC

Verified

Official record identity

FDA application number: K070155
Decision date: January 25, 2007
Published decision: Substantially Equivalent

Classification

Product code: EFB

Published parties

Applicant: Osseo Scientific, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2007-01-17
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.