510(k) K110753

MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM by Dentsply International, Inc. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2011
Date Received
March 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type