TN-Brush
510(k) K170596
TN-Brush is a Class II device made by GENOSS CO., Ltd., cleared under FDA 510(k) K170596 on 11 Sep 2017, active as of 10 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 | NumberK170596 | Date11 Sep 2017 | StatusActive |
Official records
- FDA 510(k) database K170596
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELB
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4840
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K170596
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 | |||
|---|---|---|---|---|
| TN-Brush TN-0.8 | TN-0.8 / TN-0.8 | 08809552960594 | Length 3.5 cm | On the market |
| TN-Brush TN-1.0 | TN-1.0 / TN-1.0 | 08809552960600 | Length 3.5 cm | On the market |
Similar devices
Other devices filed under FDA product code ELB (Scaler, Rotary).