FDA · official record K962442Substantially Equivalent

HYTAC APLITIP/HYTAC OSB

Name: HYTAC APLITIP/HYTAC OSB — FDA K962442
Creator: Espe GmbH & Co. Kg.
Keywords: HYTAC APLITIP/HYTAC OSB, HYTAC APLITIP/HYTAC OSB, K962442, EBF, FDA

United StatesEBFEspe GmbH & Co. Kg.

Verified

Official record identity

FDA application number: K962442
Decision date: September 11, 1996
Published decision: Substantially Equivalent

Classification

Product code: EBF

Published parties

Applicant: Espe GmbH & Co. Kg.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-06-24
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3690

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.