FDA · official record K771774Substantially Equivalent

NEW BASE FOR ORTHODONTIC APPLIANCES

Name: NEW BASE FOR ORTHODONTIC APPLIANCES — FDA K771774
Creator: Gac Intl., Inc.
Keywords: NEW BASE FOR ORTHODONTIC APPLIANCES, NEW BASE FOR ORTHODONTIC APPLIANCES, K771774, EJF, FDA

United StatesEJFGac Intl., Inc.

Verified

Official record identity

FDA application number: K771774
Decision date: September 30, 1977
Published decision: Substantially Equivalent

Classification

Product code: EJF

Published parties

Applicant: Gac Intl., Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1977-09-19
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.5410

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.