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 Heat Source For Bleaching Teeth
510(k) Number K042153
Device Name SOUTH BEACH SMILE LIGHT WHITENING SYSTEM
Applicant
Dentovations, Inc.
12101 Cullen Blvd.
Suite A
Houston,  TX  77047
Applicant Contact M. JOYCE HEINRICH
Correspondent
Dentovations, Inc.
12101 Cullen Blvd.
Suite A
Houston,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number872.6475
Classification Product Code
EEG  
Date Received08/09/2004
Decision Date 11/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-