TOKUYAMA SHIELD FORCE
FDA 510(k) clearance K100172 · decided 2010-10-21
Clearance details
- K-number
- K100172
- Device name
- TOKUYAMA SHIELD FORCE
- Applicant
- Tokuyama Dental Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-01-21
- Decision date
- 2010-10-21
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- 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.