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 Driver, Wire, And Bone Drill, Manual
510(k) Number K172164
Device Name PROPEL Device
Applicant
Propel Orthodontics, LLC
394 S. Abbott Ave.
Milpitas,  CA  95035
Applicant Contact Bryce Way
Correspondent
Propel Orthodontics, LLC
700 Thirteenth St., NW
Washington,  DC  20005
Correspondent Contact Jeffrey Shapiro
Regulation Number872.4120
Classification Product Code
DZJ  
Date Received07/18/2017
Decision Date 01/17/2018
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
-
-