FDA · official record K061629Substantially Equivalent

CERTAIN PREVAIL DENTAL IMPLANT

Name: CERTAIN PREVAIL DENTAL IMPLANT — FDA K061629
Creator: Implant Innovations, Inc.
Keywords: CERTAIN PREVAIL DENTAL IMPLANT, CERTAIN PREVAIL DENTAL IMPLANT, K061629, DZE, FDA

United StatesDZEImplant Innovations, Inc.

Verified

Official record identity

FDA application number: K061629
Decision date: February 23, 2007
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Implant Innovations, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2006-06-12
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.