Cordless Prophy System, Model: i-Polish
FDA 510(k) clearance K211531 · decided 2021-12-17
Clearance details
- K-number
- K211531
- Device name
- Cordless Prophy System, Model: i-Polish
- Applicant
- Guilin Woodpecker Medical Instrument Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-05-17
- Decision date
- 2021-12-17
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- EKX
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Guilin, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.