Endo Motor
by Foshan Cicada Dental Instrument Co., Ltd
510(k) K192649Ref T-Fine-II
Endo Motor is a remotely-driven surgical/dental system drive cable (EU MDD Class IIa; FDA Class I; FDA unclassified) made by Foshan Cicada Dental Instrument Co., Ltd, registered in EUDAMED on 29 May 2026 (Basic UDI-DI B-06974456210259), cleared under FDA 510(k) K192649 on 12 Mar 2021 and listed in FDA GUDID since 9 Aug 2024 (UDI-DI 06974456210259), active as of 8 Nov 2026.
Active
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-06974456210259 06974456210259 | Date29 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06974456210259 | Date9 Aug 2024 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | NumberK192649 | Date12 Mar 2021 | StatusActive |
Official records
- EUDAMED public site B-06974456210259
- AccessGUDID record 06974456210259
- FDA 510(k) database K192649
Across registries
- EUDAMED Basic UDI-DI B-06974456210259 registered 29 May 2026 Active
- FDA 510(k) K192649 decided 12 Mar 2021 Active
- FDA GUDID UDI-DI 06974456210259 listed 9 Aug 2024 Listed
Timeline
- Cleared FDA 510(k) K192649
- Listed FDA GUDID 06974456210259
- Registered EUDAMED B-06974456210259
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Endo Motor EUDAMEDCicada GUDID
- Generic name
- Remotely-driven surgical/dental system drive cable
- Model / reference
- T-Fine-II
- FDA applicant
- Foshan Cicada Dental Instrument Co, Ltd.
- Primary DI / UDI-DI
- 06974456210259
- Basic UDI-DI
- B-06974456210259
- 510(k) Number
- FDA product code
- EKX, LQY
- EMDN code
- L159099 Odontostomatology instruments, reusable - other
- GMDN term
- Remotely-driven surgical/dental system drive cable
- Device class
- Class IIa EUDAMEDClass I 510(k)U GUDID
- Regulation
- 21 CFR Part 872.4200
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Türkiye
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | 510(k) | GUDID |
|---|---|---|---|
| Device class | Class IIa | Class I | U |
| Sterilise before use | No | — | Yes |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 06974456210259: EUDAMED states No, FDA GUDID states Yes.
Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I and U in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes.
Devices cleared under K192649
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 | |||
|---|---|---|---|---|
| CICADA T-Fine-II | T-Fine-II | 06974456210259 | — | On the market |
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