Identity
- Trade Name
- Coltene Canalpro CL2 EUDAMEDEndo A Class FDA UDI
- Generic Name
- Dental power tool system handpiece, line-powered FDA UDI
- Device Name
- Dental controllers for contra angle handpieces EUDAMED
- Model / Reference
- ENDO a class EUDAMEDFDA UDI- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809394971345 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809394971345 EUDAMED
- FDA Product Code
- EKX FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Dental power tool system handpiece, line-powered 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental delivery system
Coltene Canalpro CL2 by Saeyang Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental delivery system.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809394971345 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Saeyang Co., Ltd.
- EUDAMED SRN
- KR-MF-000034170
- Authorised Representative
- Marathon Italia S.R.L. IT-AR-000027858
Sources (2)
- EUDAMED c5272169-88bf-4bb0-8a7f-0541020bfd9b 61 fields · synced Jul 9, 2026
- FDA UDI e0ede043-be70-4778-b2fe-5e741c74ceb9 32 fields · synced May 30, 2026