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 K911655
Device Name IMPLARETTE
Applicant
Implant Innovations International, Inc.
1897 Palm Beach Lakes Blvd.
Suite 114
West Palm Beach,  FL  33409
Applicant Contact WILLIAM CONETY
Correspondent
Implant Innovations International, Inc.
1897 Palm Beach Lakes Blvd.
Suite 114
West Palm Beach,  FL  33409
Correspondent Contact WILLIAM CONETY
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received04/12/1991
Decision Date 10/21/1991
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
-
-