• 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 K133037
Device Name GRINDGUARD
Applicant
GRIND GUARD TECHNOLOGIES, LLC
342 E. MAIN STREET
SUITE 207
LEOLA,  PA  17540
Applicant Contact WILLIAM G MCLAIN
Correspondent
GRIND GUARD TECHNOLOGIES, LLC
342 E. MAIN STREET
SUITE 207
LEOLA,  PA  17540
Correspondent Contact WILLIAM G MCLAIN
Classification Product Code
OBR  
Date Received09/26/2013
Decision Date 01/23/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-