510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K160825Substantially Equivalent

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology

Dentsply Sirona Inc, York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160825 is the FDA 510(k) clearance record for MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology, a class I device, cleared for Dentsply Sirona on under FDA product code EKX (Handpiece, Direct Drive, Ac-Powered). FDA records list 86 510(k) clearances for Dentsply Sirona, from to . As of , FDA records show no recalls naming K160825.

Clearance record

Decision date
Received
(186 days to decision)
Product code
EKX Handpiece, Direct Drive, Ac-Powered
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Dentsply Sirona 221 W. Philadelphia St., Suite 60, York PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EKX

Trailing 12 months
1 clearance under product code EKX in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EKX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260