FDA · official record K180657Substantially Equivalent

Resin for Temporary Crown & Bridge

Name: Resin for Temporary Crown & Bridge — FDA K180657
Creator: Dentis Co., Ltd.
Keywords: Resin for Temporary Crown & Bridge, Resin for Temporary Crown & Bridge, K180657, EBG, FDA

United StatesEBGDentis Co., Ltd.

Verified

Official record identity

FDA application number: K180657
Decision date: December 07, 2018
Published decision: Substantially Equivalent

Classification

Product code: EBG

Published parties

Applicant: Dentis Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2018-03-13
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3770

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.