FDA · official record K200881Substantially Equivalent

Oral-B iO Test Drive Power Brush Trial Program Kit

Name: Oral-B iO Test Drive Power Brush Trial Program Kit — FDA K200881
Creator: The Procter & Gamble Company
Keywords: Oral-B iO Test Drive Power Brush Trial Program Kit, Oral-B iO Test Drive Power Brush Trial Program Kit, K200881, JEQ, FDA

United StatesJEQThe Procter & Gamble Company

Verified

Official record identity

FDA application number: K200881
Decision date: August 27, 2020
Published decision: Substantially Equivalent

Classification

Product code: JEQ

Published parties

Applicant: The Procter & Gamble Company

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2020-04-02
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6865

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.