Cleared Traditional

K160825 - MIDWEST RDH Freedom Cordless Prophy Sys...

K160825 is the FDA 510(k) clearance for MIDWEST RDH Freedom Cordless Prophy Sys... by Dentsply Sirona. It is a Class 1 Dental device (product code EKX) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K160825 · Dentsply Sirona · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
186d
Days
Class 1
Risk

K160825 is an FDA 510(k) clearance for the MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on September 27, 2016 after a review of 186 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Sirona devices

Submission Details

510(k) Number K160825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2016
Decision Date September 27, 2016
Days to Decision 186 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 127d · This submission: 186d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 31
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K160825.
LS OIL
K173920 · J. Morita USA, Inc. · Oct 2018
Young INFINITY Cordless Handpiece System
K171377 · Young Dental Manufacturing Co. 1, LLC · Aug 2018
IS3
K180527 · Hiossen, Inc. · May 2018
QUANTEC-E ENDO SYSTEM
K990739 · Sybron Dental Specialties, Inc. · May 1999
PERIOTEST
K872171 · Siemens Medical Solutions USA, Inc. · Jun 1987
PERITONEAL DIALYSIS SYSTEM
K760724 · Physio-Control Corp. · Nov 1976