FDA · official record K213609Substantially Equivalent

NOVA RESIN dual cure, self adhesive resin cement

Name: NOVA RESIN dual cure, self adhesive resin cement — FDA K213609
Creator: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
Keywords: NOVA RESIN dual cure, self adhesive resin cement, NOVA RESIN dual cure, self adhesive resin cement, K213609, EMA, FDA

United StatesEMAImicryl Dis Malzemeleri Sanayi VE Ticaret AS

Verified

Official record identity

FDA application number: K213609
Decision date: August 09, 2022
Published decision: Substantially Equivalent

Classification

Product code: EMA

Published parties

Applicant: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2021-11-15
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.