PROXEO Twist Cordless Polishing System PL-40 H
K-Number: K201703 · 2021-02-24
ApplicantW&H Dentalwerk Buermoos GmbH
Decision Date2021-02-24
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
PROXEO Twist Cordless Polishing System PL-40 H is a medical device manufactured by W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2021-02-24 under approval number K201703. 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 PROXEO Twist Cordless Polishing System PL-40 H?
PROXEO Twist Cordless Polishing System PL-40 H is a medical device that received FDA 510(k) clearance on 2021-02-24. It is manufactured by W&H Dentalwerk Buermoos GmbH. The 510(k) number is K201703.
When was PROXEO Twist Cordless Polishing System PL-40 H approved by the FDA?
PROXEO Twist Cordless Polishing System PL-40 H received FDA 510(k) clearance on 2021-02-24, under approval number K201703.
What company makes PROXEO Twist Cordless Polishing System PL-40 H?
PROXEO Twist Cordless Polishing System PL-40 H is manufactured by W&H Dentalwerk Buermoos GmbH.
What is the FDA product code for PROXEO Twist Cordless Polishing System PL-40 H?
The FDA product code for PROXEO Twist Cordless Polishing System PL-40 H 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.