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FDA 510(k)

Cordless Prophy System, Model: i-Polish

K-Number: K211531 · 2021-12-17

ApplicantGuilin Woodpecker Medical Instrument Co., Ltd.
Decision Date2021-12-17
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Cordless Prophy System, Model: i-Polish is a medical device manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-12-17 under approval number K211531. 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 Cordless Prophy System, Model: i-Polish?

Cordless Prophy System, Model: i-Polish is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K211531.

When was Cordless Prophy System, Model: i-Polish approved by the FDA?

Cordless Prophy System, Model: i-Polish received FDA 510(k) clearance on 2021-12-17, under approval number K211531.

What company makes Cordless Prophy System, Model: i-Polish?

Cordless Prophy System, Model: i-Polish is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd..

What is the FDA product code for Cordless Prophy System, Model: i-Polish?

The FDA product code for Cordless Prophy System, Model: i-Polish is EKX.

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Other Devices by Guilin Woodpecker Medical Instrument Co., Ltd.

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Related Devices (Code: 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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