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FDA 510(k)

MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM

K-Number: K110753 · 2011-06-06

ApplicantDentsply International, Inc.
Decision Date2011-06-06
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International, Inc.. It received FDA 510(k) clearance on 2011-06-06 under 510(k) number K110753. 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?

MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-06. The listed applicant is Dentsply International, Inc.. The 510(k) number is K110753.

When did MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM receive FDA 510(k) clearance?

MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM received FDA 510(k) clearance on 2011-06-06, under 510(k) number K110753.

Who is the listed applicant for MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM?

The FDA 510(k) record lists Dentsply International, Inc. 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?

The FDA product code for MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM 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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