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 Burnisher, Operative
510(k) Number K912149
Device Name HARDCOATED PLASTIC FILLING INSTRUMENT
Applicant
Premier Dental Products Co.
1710 Romano Dr.
P.O. Box 111
Norristown,  PA  19401
Applicant Contact WILLIAM J FREZEL
Correspondent
Premier Dental Products Co.
1710 Romano Dr.
P.O. Box 111
Norristown,  PA  19401
Correspondent Contact WILLIAM J FREZEL
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received05/15/1991
Decision Date 06/24/1991
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
-
-