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Vulkan® Internal Hex. Pilar Angulado 15º x 3.0mm
EUDAMEDClass IIb (EU MDR)
Ref VINH070315Model TCPCE
Identity
- Trade Name
- Vulkan® Internal Hex. Pilar Angulado 15º x 3.0mm EUDAMED
- Device Name
- Cementable Abutments EUDAMED
- Model / Reference
- TCPCE EUDAMEDVINH070315 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435539230000 EUDAMED
- Basic UDI-DI
- 84355392210TJ EUDAMED
- EMDN Code
- P010299 ODONTOLOGICAL PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Category: Dental implant suprastructure, permanent, preformed
Vulkan® Internal Hex. Pilar Angulado 15º x 3.0mm by Titanimplant, S.l. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, permanent, preformed.
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- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
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- EZ Post — Megagen Implant Co. Ltd · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 84355392210TJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Titanimplant, S.l.
- EUDAMED SRN
- ES-MF-000003263
Sources (1)
- EUDAMED 8e01d9c8-1299-44a9-84fe-263503f9bc3a 61 fields · synced Jun 18, 2026