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FDA 510(k)

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology

K-Number: K160825 · 2016-09-27

ApplicantDentsply Sirona
Decision Date2016-09-27
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2016-09-27 under 510(k) number K160825. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology?

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is Dentsply Sirona. The 510(k) number is K160825.

When did MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology receive FDA 510(k) clearance?

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology received FDA 510(k) clearance on 2016-09-27, under 510(k) number K160825.

Who is the listed applicant for MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology?

The FDA product code for MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology is EKX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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