FDA · official record K931229Substantially Equivalent

VARIGLASS VLC GLASS IONOMER

Name: VARIGLASS VLC GLASS IONOMER — FDA K931229
Creator: Dentsply Intl.
Keywords: VARIGLASS VLC GLASS IONOMER, VARIGLASS VLC GLASS IONOMER, K931229, EMA, FDA

United StatesEMADentsply Intl.

Verified

Official record identity

FDA application number: K931229
Decision date: July 08, 1993
Published decision: Substantially Equivalent

Classification

Product code: EMA

Published parties

Applicant: Dentsply Intl.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1993-03-10
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3275

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.