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Alpha-Core Sc Self Cure Core Build Up Material Kit - White
EUDAMEDClass IIa (EU MDR)
Ref 120-0025-002Ref 120-0026-002
Identity
- Trade Name
- ALPHA-CORE SC SELF CURE CORE BUILD UP MATERIAL KIT - WHITE EUDAMEDALPHA-CORE SC SELF CURE CORE BUILD-UP MATERIAL KIT - NATURAL EUDAMED
- Device Name
- Core Material EUDAMED
- Model / Reference
- 120-0025-002 EUDAMED120-0026-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D73512000250020 EUDAMED+D73512000260020 EUDAMED
- Basic UDI-DI
- ++D735CoreMaterialZW EUDAMED
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Alpha-Core Sc Self Cure Core Build Up Material Kit - White by Dental Technologies, Inc. — Class IIa — 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 | ++D735CoreMaterialZW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dental Technologies, Inc.
- EUDAMED SRN
- US-MF-000027130
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 94a4f7ec-f9ed-4084-9837-085d42ab2eee 61 fields · synced Jul 17, 2026
- EUDAMED 7d2ed377-39d3-41a5-a0ca-454782f27e54 61 fields · synced May 18, 2026