Teethan 2.0
by Bts SpA
Teethan 2.0 (BTSEMB1BM) is a Class II device made by Bts SpA, cleared under FDA 510(k) K161716 on 21 Dec 2016 and listed in FDA GUDID since 26 Sep 2017 (UDI-DI B179THN2), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB179THN2 | Date26 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161716 | Date21 Dec 2016 | StatusActive |
Official records
- FDA 510(k) database K161716
Across registries
- FDA 510(k) K161716 decided 21 Dec 2016 Active
- FDA GUDID UDI-DI B179THN2 listed 26 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K161716
- Listed FDA GUDID B179THN2
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Teethan
- Generic name
- Electromyograph
- Model / Ref / Catalog
- 2.0, BTSEMB1BM
- Primary DI / UDI-DI
- B179THN2
- 510(k) Number
- FDA product code
- KZM
- GMDN term
- Electromyograph
- Device class
- Class II
- Regulation number
- 890.1375
- GUDID distribution status
- In Commercial Distribution
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