UF(II) Bar holder abutment
FDA 510(k) clearance K193404 · decided 2020-05-18
Clearance details
- K-number
- K193404
- Device name
- UF(II) Bar holder abutment
- Applicant
- Dio Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-12-06
- Decision date
- 2020-05-18
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Busan, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.