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 Orthodontic Vibratory Accessory
510(k) Number K183018
Device Name VPro5
Applicant
Propel Orthodontics, LLC
394 S. Abbott Ave.
Milpitas,  CA  95035
Applicant Contact Bryce Way
Correspondent
Propel Orthodontics, LLC
394 S. Abbott Ave.
Milpitas,  CA  95035
Correspondent Contact Bryce Way
Regulation Number872.5470
Classification Product Code
OYH  
Date Received10/31/2018
Decision Date 11/01/2019
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
-
-