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X-Smart Go Cordless endo motor with integrated apex locator
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref B00XSGO000000Model EM-07 Cordless endo motor with integrated apex locator510(k) K232551Ref BRFXSGO000000Model X-Smart Go Cordless endo motor with integrated apex locator (Refurbished)
Identity
- Trade Name
- X-Smart Go Cordless endo motor with integrated apex locator EUDAMEDX-Smart Go Cordless endo motor with integrated apex locator (Refurbished) EUDAMED
- Device Name
- X-Smart Go Cordless endo motor with integrated apex locator EUDAMEDX-Smart Go Cordless endo motor with integrated apex locator (Refurbished) EUDAMED
- Model / Reference
- EM-07 Cordless endo motor with integrated apex locator EUDAMEDB00XSGO000000 EUDAMEDX-Smart Go Cordless endo motor with integrated apex locator (Refurbished) EUDAMEDBRFXSGO000000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D100B00XSGO000000 EUDAMEDD100BRFXSGO000000 EUDAMED
- Basic UDI-DI
- ++D100B00XSGO00000093 EUDAMED++D100BRFXSGO0000003R EUDAMED
- Direct Marketing DI
- D100B00XSGO000000 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
X-Smart Go Cordless endo motor with integrated apex locator by Forum Engineering Technologies (96) Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232551 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++D100B00XSGO00000093 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Forum Engineering Technologies (96) Ltd.
- EUDAMED SRN
- IL-MF-000023254
- FDA Applicant
- Forum Engineering Technologies (96) , Ltd.
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (3)
- EUDAMED f888e69d-f953-4b5b-af99-965bc703776b 85 fields · synced Jul 14, 2026
- EUDAMED 76e45c3f-e475-446a-bb87-40d4be250d9b 61 fields · synced May 18, 2026
- FDA 510(k) K232551 1 fields · synced May 18, 2026