FDA · official record K900117Substantially Equivalent

STELLITE COBALT/CHROMIUM BASE METAL ALLOY

Name: STELLITE COBALT/CHROMIUM BASE METAL ALLOY — FDA K900117
Creator: D.C. Dental Specialties
Keywords: STELLITE COBALT/CHROMIUM BASE METAL ALLOY, STELLITE COBALT/CHROMIUM BASE METAL ALLOY, K900117, EJH, FDA

United StatesEJHD.C. Dental Specialties

Verified

Official record identity

FDA application number: K900117
Decision date: April 02, 1990
Published decision: Substantially Equivalent

Classification

Product code: EJH

Published parties

Applicant: D.C. Dental Specialties

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1990-01-09
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3710

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.