SOFRELINER TOUGH S
FDA 510(k) clearance K112445 · decided 2011-10-28
Clearance details
- K-number
- K112445
- Device name
- SOFRELINER TOUGH S
- Applicant
- Tokuyama Dental Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-08-24
- Decision date
- 2011-10-28
- Days to decision
- 65 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.