FDA · official record K071484Substantially Equivalent

PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040

Name: PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 — FDA K071484
Creator: Glustitch, Inc.
Keywords: PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040, PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040, K071484, EMA, FDA

United StatesEMAGlustitch, Inc.

Verified

Official record identity

FDA application number: K071484
Decision date: October 10, 2007
Published decision: Substantially Equivalent

Classification

Product code: EMA

Published parties

Applicant: Glustitch, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2007-05-30
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.