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i-XR3
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 95520454, 95520663Model Micromotors for dental use
by CEFLA s.c.
Identity
- Trade Name
- i-XR3 EUDAMEDStern Weber FDA UDI
- Generic Name
- Dental surgical power tool motor, electric FDA UDI
- Device Name
- The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear-reducing, or gear increasing speed. They are intended for professional use in dental surgery such as: preventive dentistry, restorative applications, endodontic treatment, prosthetic applications and implantology practices. FDA UDI
- Model / Reference
- Micromotors for dental use EUDAMED95520454, 95520663 EUDAMEDi-XR3 FDA UDI
- Description
- The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear-reducing, or gear increasing speed. They are intended for professional use in dental surgery such as: preventive dentistry, restorative applications, endodontic treatment, prosthetic applications and implantology practices. FDA UDI
Identifiers
- Catalog Number
- 95520663 FDA UDI
- Primary DI / UDI-DI
- 08033837930723 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793TRDENMOTA001LV EUDAMED
- Direct Marketing DI
- 08033837930723 EUDAMED
- 510(k) Number
- K213022 FDA UDI
- FDA Product Code
- EBW FDA UDI
- EMDN Code
- Z12119080 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Dental surgical power tool motor, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
i-XR3 by CEFLA s.c. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803383793TRDENMOTA001LV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (3)
- EUDAMED bf0c7475-7adc-4319-a9eb-a6fdf8dea292 61 fields · synced Jul 19, 2026
- FDA UDI d8cda756-fe6f-49fe-b788-b137571fec68 37 fields · synced May 30, 2026
- EUDAMED bf0c7475-7adc-4319-a9eb-a6fdf8dea292-1 61 fields · synced Jun 10, 2026