FDA · official record K852630Substantially Equivalent

DEN-MAT PAINT-ON RUBBER DAM

Name: DEN-MAT PAINT-ON RUBBER DAM — FDA K852630
Creator: Den-Mat Corp.
Keywords: DEN-MAT PAINT-ON RUBBER DAM, DEN-MAT PAINT-ON RUBBER DAM, K852630, EIE, FDA

United StatesEIEDen-Mat Corp.

Verified

Official record identity

FDA application number: K852630
Decision date: December 18, 1985
Published decision: Substantially Equivalent

Classification

Product code: EIE

Published parties

Applicant: Den-Mat Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1985-06-20
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6300

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.