SmarTooth
FDA 510(k) clearance K231722 · decided 2024-05-01
Clearance details
- K-number
- K231722
- Device name
- SmarTooth
- Applicant
- Smartooth Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-06-13
- Decision date
- 2024-05-01
- Days to decision
- 323 days
- Clearance type
- Traditional
- Product code
- NBL
- Device class
- 2
- Regulation number
- 872.1745
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.