FDA · official record K102981Substantially Equivalent

ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM

Name: ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM — FDA K102981
Creator: Ace Surgical Supply Company, Inc.
Keywords: ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM, ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM, K102981, DZE, FDA

United StatesDZEAce Surgical Supply Company, Inc.

Verified

Official record identity

FDA application number: K102981
Decision date: December 20, 2010
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Ace Surgical Supply Company, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2010-10-07
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3640

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.