FDA · official record K964573Substantially Equivalent

PIEDMONT 70 (CH-35)

Name: PIEDMONT 70 (CH-35) — FDA K964573
Creator: Gateway Alloys, Inc.
Keywords: PIEDMONT 70 (CH-35), PIEDMONT 70 (CH-35), K964573, EJT, FDA

United StatesEJTGateway Alloys, Inc.

Verified

Official record identity

FDA application number: K964573
Decision date: December 06, 1996
Published decision: Substantially Equivalent

Classification

Product code: EJT

Published parties

Applicant: Gateway Alloys, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-11-14
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3060

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.