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Alpha-Core Dc Dual Cure Core Build Up Kit, Natural A2
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 122-0003-002
Identity
- Trade Name
- ALPHA-CORE DC DUAL CURE CORE BUILD UP KIT, NATURAL A2 EUDAMED
- Device Name
- Core Material EUDAMED
- Model / Reference
- 122-0003-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D73512200030020 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 Dc Dual Cure Core Build Up Kit, Natural A2 by Dental Technologies, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070191 | Class IIa | Active |
| 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 ac6878b5-5354-4bef-b290-9b2ec6b05f77 61 fields · synced Jul 12, 2026
- FDA 510(k) K070191 1 fields · synced May 18, 2026