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I-Cement Abutment Analog
EUDAMEDClass I (EU MDR)
Ref I-SILCEA40Ref I-SILCEA50Ref I-SILCEA65
by Novodent SA
Identity
- Trade Name
- I-Cement Abutment Analog EUDAMED
- Device Name
- Bone Level Mini Fixture Lab Analog EUDAMED
- Model / Reference
- I-SILCEA40 EUDAMEDI-SILCEA50 EUDAMEDI-SILCEA65 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630188204896 EUDAMED07630188204902 EUDAMED07630188204919 EUDAMED
- Basic UDI-DI
- 764016818003D7 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
I-Cement Abutment Analog by Novodent SA — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 764016818003D7 | Class I | Active |
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Manufacturer
- Manufacturer
- Novodent SA
- EUDAMED SRN
- CH-MF-000023309
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 038e3aee-0239-47ed-a875-15f44e5c9188 61 fields · synced Jul 28, 2026
- EUDAMED 80bd321c-1763-4191-a610-aa40d07689cc 61 fields · synced May 18, 2026
- EUDAMED 0ab91703-d4f3-4567-b3e7-a674dc93063d 61 fields · synced May 18, 2026