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 K150492
Device Name Ora-GUARD Dental Grind Guard
Applicant
Bite Tech Inc.
20 Glover Avenue
Norwalk,  CT  06850
Applicant Contact Jeff Padovan
Correspondent
HYMAN, PHELPS & MCNAMARA, P.C.
700 13TH STREET NW, SUITE 1200
WASHINGTON,  DC  20005
Correspondent Contact Alex Varond
Classification Product Code
OBR  
Date Received02/25/2015
Decision Date 02/19/2016
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-