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10 Tenax Fiber Trans Posts, 1.5mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 60018576
Identity
- Trade Name
- 10 Tenax Fiber Trans Posts, 1.5mm EUDAMEDTenax Fiber Trans FDA UDI
- Generic Name
- Root canal post, preformed FDA UDI
- Device Name
- Tenax Fiber Trans EUDAMEDTenax Fiber Trans Size 1.5 FDA UDI
- Model / Reference
- 60018576 EUDAMEDFDA UDI
- Description
- Tenax Fiber Trans Size 1.5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661600185761 EUDAMEDFDA UDI
- Basic UDI-DI
- B-D661600185761 EUDAMED
- FDA Product Code
- ELR FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Root canal post, preformed FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3810 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
10 Tenax Fiber Trans Posts, 1.5mm by Coltene/Whaledent Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-D661600185761 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED 7435fe5b-3d57-4e06-a0ea-0b7a24a640e5 61 fields · synced Jul 9, 2026
- FDA UDI 69623cd9-992a-49a9-a17b-c85ca50b8206 33 fields · synced May 30, 2026