Identity
- Trade Name
- 5 Tenax Fiber Trans Posts, 1.3mm EUDAMEDTENAX Fiber Trans FDA UDI
- Generic Name
- Root canal post, preformed FDA UDI
- Device Name
- Tenax Fiber Trans EUDAMEDTENAX Fiber Trans Size 1.3 FDA UDI
- Model / Reference
- TFT13 EUDAMEDFDA UDI
- Description
- TENAX Fiber Trans Size 1.3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661TFT131 EUDAMEDFDA UDI
- Basic UDI-DI
- B-D661TFT131 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental appliance fabrication material, ceramic
5 Tenax Fiber Trans Posts, 1.3mm by Coltene/Whaledent Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-D661TFT131 | 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 d3ad6c57-70f4-487a-9d17-0a39631e979e 61 fields · synced Jul 14, 2026
- FDA UDI b59cbad9-e8b4-4295-8c03-479c229afffd 33 fields · synced May 29, 2026