Endo Ultrasonic Activator
FDA 510(k) clearance K222096 · decided 2023-03-23
Clearance details
- K-number
- K222096
- Device name
- Endo Ultrasonic Activator
- Applicant
- Foshan Coxo Medical Instrument Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-18
- Decision date
- 2023-03-23
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Foshan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.