FDA · official record K961381Substantially Equivalent

KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS

Name: KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS — FDA K961381
Creator: The Emerging Technologies Group
Keywords: KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS, KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS, K961381, DZE, FDA

United StatesDZEThe Emerging Technologies Group

Verified

Official record identity

FDA application number: K961381
Decision date: September 09, 1997
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: The Emerging Technologies Group

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-03-19
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.