Tokuyama Sofreliner Tough
by Tokuyama Dental Corporation
510(k) K030663
Tokuyama Sofreliner Tough is a Class II device made by Tokuyama Dental Corporation, cleared under FDA 510(k) K030663 on 29 May 2003, 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 | NumberK030663 | Date29 May 2003 | StatusActive |
Official records
- FDA 510(k) database K030663
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- Withdrawn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
Devices cleared under K030663
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Sofreliner Tough 23351 | 23351 | 04548190233519 | — | On the market |
| Sofreliner Tough 23356 | 23356 | 04548190233564 | — | On the market |
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