FDA · official record K820389Substantially Equivalent

A DENTAL AMALGAM ALLOY (UNNAMED

Name: A DENTAL AMALGAM ALLOY (UNNAMED — FDA K820389
Creator: Dentsply Intl.
Keywords: A DENTAL AMALGAM ALLOY (UNNAMED, A DENTAL AMALGAM ALLOY (UNNAMED, K820389, EJJ, FDA

United StatesEJJDentsply Intl.

Verified

Official record identity

FDA application number: K820389
Decision date: March 11, 1982
Published decision: Substantially Equivalent

Classification

Product code: EJJ

Published parties

Applicant: Dentsply Intl.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1982-02-10
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3070

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.