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 Varnish, Cavity
510(k) Number K233768
Device Name Papacarie Duo
Applicant
Elevate Oral Care
346 Pike Rd
Suite 5
West Palm Beach,  FL  33411
Applicant Contact Steven Pardue
Correspondent
Elevate Oral Care
346 Pike Rd
Suite 5
West Palm Beach,  FL  33411
Correspondent Contact Steven Pardue
Regulation Number872.3260
Classification Product Code
LBH  
Subsequent Product Code
KLE  
Date Received11/24/2023
Decision Date 07/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-