FDA · official record K960634Substantially Equivalent

TITANIUM HEALING CAPS

Name: TITANIUM HEALING CAPS — FDA K960634
Creator: The Straumann Co.
Keywords: TITANIUM HEALING CAPS, TITANIUM HEALING CAPS, K960634, DZE, FDA

United StatesDZEThe Straumann Co.

Verified

Official record identity

FDA application number: K960634
Decision date: June 18, 1996
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: The Straumann Co.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-02-14
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.