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 Mouthguard, Over-The-Counter
510(k) Number K132469
Device Name THE BITE GUARD
Applicant
INTERNATIONAL PROFIT BUILDERS, INC.
7045 PALM AVE
HIGHLAND,  CA  92346
Applicant Contact BRYAN TAPOCIK
Correspondent
INTERNATIONAL PROFIT BUILDERS, INC.
7045 PALM AVE
HIGHLAND,  CA  92346
Correspondent Contact BRYAN TAPOCIK
Classification Product Code
OBR  
Date Received08/07/2013
Decision Date 02/28/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-