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 Toothbrush, Manual
510(k) Number K892264
Device Name ORALCHEK SUPER-SOFT BRUSH
Applicant
Pfizer, Inc.
235 E. 42nd St.
Ny,  NY  10017
Applicant Contact DAVID C OPPENHEIMER
Correspondent
Pfizer, Inc.
235 E. 42nd St.
Ny,  NY  10017
Correspondent Contact DAVID C OPPENHEIMER
Regulation Number872.6855
Classification Product Code
EFW  
Date Received04/05/1989
Decision Date 06/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-