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 Instrument, Diamond, Dental
510(k) Number K901262
Device Name F.G. LASER (DENTAL BUR)
Applicant
Diamond Rotary and Carbide Intl.
P.O. Box 3092
Winnipeg, Manitoba
Canada R3c 4e5,  CA
Applicant Contact J WILLOUGHBY
Correspondent
Diamond Rotary and Carbide Intl.
P.O. Box 3092
Winnipeg, Manitoba
Canada R3c 4e5,  CA
Correspondent Contact J WILLOUGHBY
Regulation Number872.4535
Classification Product Code
DZP  
Date Received03/16/1990
Decision Date 07/09/1990
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
-
-