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 Handpiece, Direct Drive, Ac-Powered
510(k) Number K160825
Device Name MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology
Applicant
Dentsply Sirona
221 W. Philadelphia St., Suite 60
York,  PA  17404
Applicant Contact Helen Lewis
Correspondent
Dentsply Sirona
221 W. Philadelphia St., Suite 60
York,  PA  17404
Correspondent Contact Helen Lewis
Regulation Number872.4200
Classification Product Code
EKX  
Date Received03/25/2016
Decision Date 09/27/2016
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
-
-