TOKUYAMA TISSUECARE
FDA 510(k) clearance K081554 · decided 2009-03-18
Clearance details
- K-number
- K081554
- Device name
- TOKUYAMA TISSUECARE
- Applicant
- Tokuyama Dental Corporation
- Decision
- Substantially Equivalent
- Date received
- 2008-06-03
- Decision date
- 2009-03-18
- Days to decision
- 288 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.