FDA · official record K982305Substantially Equivalent

SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT

Name: SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT — FDA K982305
Creator: Sulzer Calcitek, Inc.
Keywords: SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT, SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT, K982305, DZE, FDA

United StatesDZESulzer Calcitek, Inc.

Verified

Official record identity

FDA application number: K982305
Decision date: September 22, 1998
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Sulzer Calcitek, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1998-07-01
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.