Cordless Prophy System, Model: i-Polish
FDA 510(k) K211531 · Guilin Woodpecker Medical Instrument Co., Ltd.
510(k) numberK211531
Submission
- Device name
- Cordless Prophy System, Model: i-Polish
- Applicant
- Guilin Woodpecker Medical Instrument Co., Ltd.
Guilin, CN - Received
- May 17, 2021
- Decision date
- December 17, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Cordless Prophy System, Model: i-Polish cleared by the FDA?
Cordless Prophy System, Model: i-Polish (K211531) received a 510(k) decision of Substantially Equivalent on December 17, 2021, 214 days after the submission was received.
What is the product code of K211531?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.