DIOnavi-Denture
FDA 510(k) clearance K193623 · decided 2020-10-22
Clearance details
- K-number
- K193623
- Device name
- DIOnavi-Denture
- Applicant
- Dio Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-12-26
- Decision date
- 2020-10-22
- Days to decision
- 301 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- 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.