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Endo Motor

FDA 510(k)FDA UDIEUDAMED

Class I (US FDA 510(k))

510(k) K192649Ref T-Fine-II

by Foshan CICADA Dental Instrument Co., Ltd.

Identity

Trade Name
Endo Motor EUDAMED
CICADA FDA UDI
Generic Name
Remotely-driven surgical/dental system drive cable FDA UDI
Device Name
Endo Motor EUDAMEDFDA UDI
Model / Reference
T-Fine-II EUDAMEDFDA UDI
Description
Endo Motor FDA UDI

Identifiers

Primary DI / UDI-DI
06974456210259 EUDAMEDFDA UDI
Basic UDI-DI
B-06974456210259 EUDAMED
510(k) Number
K192649 FDA 510(k)FDA UDI
FDA Product Code
EKX FDA 510(k)FDA UDI
LQY FDA UDI
EMDN Code
L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Remotely-driven surgical/dental system drive cable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA 510(k)
U FDA UDI
Legislation / Framework
21 CFR Part 872.4200 FDA 510(k)
Regulation Number
872.4200 FDA 510(k)FDA UDI
Market of Registration
Türkiye EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Endo Motor by Foshan CICADA Dental Instrument Co., Ltd. — Class I — MDD, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Foshan CICADA Dental Instrument Co., Ltd.
FDA Applicant
Foshan Cicada Dental Instrument Co, Ltd.

Sources (3)

  • FDA 510(k) K192649 24 fields · synced Jul 15, 2026
  • FDA UDI be051e84-ef25-4ab9-b69c-39087e176436 34 fields · synced May 30, 2026
  • EUDAMED 0e828fd0-868a-4eec-82ca-7a8417093ba1 61 fields · synced Jul 15, 2026