FDA · official record K130186Substantially Equivalent

DENTEK EASY BRUSH WITH FLUORIDE

Name: DENTEK EASY BRUSH WITH FLUORIDE — FDA K130186
Creator: Den Tek Oral Care, Inc.
Keywords: DENTEK EASY BRUSH WITH FLUORIDE, DENTEK EASY BRUSH WITH FLUORIDE, K130186, EFW, FDA

United StatesEFWDen Tek Oral Care, Inc.

Verified

Official record identity

FDA application number: K130186
Decision date: July 15, 2013
Published decision: Substantially Equivalent

Classification

Product code: EFW

Published parties

Applicant: Den Tek Oral Care, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2013-01-25
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6855

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.