Titanium Turbine
FDA 510(k) clearance K230888 · decided 2023-06-02
Clearance details
- K-number
- K230888
- Device name
- Titanium Turbine
- Applicant
- Nakanishi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-03-31
- Decision date
- 2023-06-02
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Kanuma, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.