Vioseal X
by Spident
510(k) K262050
Vioseal X is a Class II device made by Spident, cleared under FDA 510(k) K262050 on 11 Sep 2026, 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 | NumberK262050 | Date11 Sep 2026 | StatusActive |
Official records
- FDA 510(k) database K262050
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KIF
- FDA applicant
- Spident Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3820
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K262050
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 | |||
|---|---|---|---|---|
| Vioseal X-a | Vioseal X-a | 08809262950922 | — | On the market |
| Vioseal X-a0.5 | Vioseal X-a0.5 | 08809262950939 | — | On the market |
| Vioseal X-s | Vioseal X-s | 08809262950946 | — | On the market |
| Vioseal X-s0.5 | Vioseal X-s0.5 | 08809262950953 | — | On the market |