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 Varnish, Cavity
510(k) Number K062176
FOIA Releasable 510(k) K062176
Device Name RELIEF ACP ORAL CARE GEL
Applicant
Discus Dental, Inc.
8550 Higuera St.
Culver City,  CA  90232
Applicant Contact STEVEN L ZIEMBA
Correspondent
Discus Dental, Inc.
8550 Higuera St.
Culver City,  CA  90232
Correspondent Contact STEVEN L ZIEMBA
Regulation Number872.3260
Classification Product Code
LBH  
Date Received07/31/2006
Decision Date 01/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-