FDA · official record K052997Substantially Equivalent

ZIMMER DENTAL ONE-PIECE IMPLANT

Name: ZIMMER DENTAL ONE-PIECE IMPLANT — FDA K052997
Creator: Zimmer Dental, Inc.
Keywords: ZIMMER DENTAL ONE-PIECE IMPLANT, ZIMMER DENTAL ONE-PIECE IMPLANT, K052997, DZE, FDA

United StatesDZEZimmer Dental, Inc.

Verified

Official record identity

FDA application number: K052997
Decision date: January 23, 2006
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Zimmer Dental, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2005-10-25
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.