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 K883761
Device Name IONODENT II (6 VOLTS)
Applicant
U.S. Apatite Corp.
7841 Alabama Ave.
Suite #5
Canoga Park,  CA  91304
Applicant Contact EDWARD M BASILE
Correspondent
U.S. Apatite Corp.
7841 Alabama Ave.
Suite #5
Canoga Park,  CA  91304
Correspondent Contact EDWARD M BASILE
Regulation Number872.6855
Classification Product Code
EFW  
Date Received09/06/1988
Decision Date 12/05/1988
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
-
-