FDA · official record K151588Substantially Equivalent

maxFit II Dental Implant System

Name: maxFit II Dental Implant System — FDA K151588
Creator: Taiwan Implant Technology Company, Ltd.
Keywords: maxFit II Dental Implant System, maxFit II Dental Implant System, K151588, DZE, FDA

United StatesDZETaiwan Implant Technology Company, Ltd.

Verified

Official record identity

FDA application number: K151588
Decision date: April 25, 2016
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Taiwan Implant Technology Company, Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2015-06-11
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.