Sofreliner Tough S
by Tokuyama Dental Corporation
510(k) K112445
Sofreliner Tough S is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K112445 on 28 Oct 2011, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112445 | Date28 Oct 2011 | StatusActive |
Official records
- FDA 510(k) database K112445
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBI
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3760
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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