FDA · official record K991974Substantially Equivalent

FUTURA GLASS IONOMER SILVER REINFORCED

Name: FUTURA GLASS IONOMER SILVER REINFORCED — FDA K991974
Creator: Ab Ardent
Keywords: FUTURA GLASS IONOMER SILVER REINFORCED, FUTURA GLASS IONOMER SILVER REINFORCED, K991974, EMA, FDA

United StatesEMAAb Ardent

Verified

Official record identity

FDA application number: K991974
Decision date: September 17, 1999
Published decision: Substantially Equivalent

Classification

Product code: EMA

Published parties

Applicant: Ab Ardent

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1999-06-11
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.