FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
Cordless Prophy System, Model: i-Polish
K Number: K211531
·
Decision Dec 17, 2021
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
85
Applicant Total
10
Review Days
214
Basic Information
- Device Name
- Cordless Prophy System, Model: i-Polish
- K Number
- K211531
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guilin Woodpecker Medical Instrument Co., Ltd.
- Date Received
- May 17, 2021
- Decision Date
- December 17, 2021
- Product Code
- EKX
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | FDA class 1 | Dental |
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