OK Handpiece
FDA 510(k) clearance K221814 · decided 2022-07-15
Clearance details
- K-number
- K221814
- Device name
- OK Handpiece
- Applicant
- Jaintek Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2022-06-22
- Decision date
- 2022-07-15
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Ansan-Si, KR
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.