FDA · official record K942031Substantially Equivalent

CAULK TOOTH CONDITIONER GEL AND SYRINGE

Name: CAULK TOOTH CONDITIONER GEL AND SYRINGE — FDA K942031
Creator: Dentsply Intl.
Keywords: CAULK TOOTH CONDITIONER GEL AND SYRINGE, CAULK TOOTH CONDITIONER GEL AND SYRINGE, K942031, EBF, FDA

United StatesEBFDentsply Intl.

Verified

Official record identity

FDA application number: K942031
Decision date: June 10, 1994
Published decision: Substantially Equivalent

Classification

Product code: EBF

Published parties

Applicant: Dentsply Intl.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1994-04-26
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3690

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.