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, Prescription
510(k) Number K082723
Device Name GRINDGUARD
Applicant
Grind Guard Technologies, LLC
342 E. Main St.
Suite 207
Leola,  PA  17540
Applicant Contact BILL MCLAIN
Correspondent
Grind Guard Technologies, LLC
342 E. Main St.
Suite 207
Leola,  PA  17540
Correspondent Contact BILL MCLAIN
Classification Product Code
MQC  
Date Received09/17/2008
Decision Date 08/31/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-