Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Saliva, Artificial
510(k) Number K201277
Device Name Oral-B Dry Mouth Oral Rinse
Applicant
The Procter & Gamble Company
1 Procter & Gamble Plz.
Cincinnati,  OH  45202
Applicant Contact Michael A Kaminski
Correspondent
The Procter & Gamble Company
8700 Mason Montgomery Rd.
Mason,  OH  45040
Correspondent Contact Michael A Kaminski
Classification Product Code
LFD  
Date Received05/13/2020
Decision Date 09/02/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-