FDA 510(k)

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology

K-Number: K160825 · 2016-09-27

Decision Date2016-09-27

Product CodeEKX

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2016-09-27 under approval 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. It is manufactured by Dentsply Sirona. The 510(k) number is K160825.

When was MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology approved by the FDA?

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

What company makes MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology?

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology is manufactured by Dentsply Sirona.

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

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