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 Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K894639
Device Name SKYROCK AND LIGHT SUPERBOND
Applicant
Dent Zar, Inc.
8721 Santa Monica Blvd.
Box 650
Los Angeles,  CA  90069
Applicant Contact DAVID ZAROTSKY
Correspondent
Dent Zar, Inc.
8721 Santa Monica Blvd.
Box 650
Los Angeles,  CA  90069
Correspondent Contact DAVID ZAROTSKY
Regulation Number872.3750
Classification Product Code
DYH  
Date Received07/24/1989
Decision Date 10/20/1989
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
-
-