FDA · official record K033785Substantially Equivalent

PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE

Name: PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE — FDA K033785
Creator: Discus Dental, Inc.
Keywords: PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE, PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE, K033785, EJR, FDA

United StatesEJRDiscus Dental, Inc.

Verified

Official record identity

FDA application number: K033785
Decision date: June 18, 2004
Published decision: Substantially Equivalent

Classification

Product code: EJR

Published parties

Applicant: Discus Dental, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2003-12-04
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6030

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.