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 K222424
Device Name Protect-It Custom Fit Dental Guard
Applicant
DOC Brands, Inc.
407 E. Lancaster Avenue
Wayne,  PA  19087
Applicant Contact Sean Stubbs
Correspondent
DOC Brands, Inc.
407 E. Lancaster Avenue
Wayne,  PA  19087
Correspondent Contact Eric Mowell
Classification Product Code
OBR  
Date Received08/11/2022
Decision Date 10/07/2022
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-