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Alpha-Dent Light Cure Hybrid Composite 4 Syringe Kit W/ Etchant Gel (custom)
EUDAMEDClass IIa (EU MDR)
Ref 101-0016-001
Identity
- Trade Name
- ALPHA-DENT LIGHT CURE HYBRID COMPOSITE 4 SYRINGE KIT W/ ETCHANT GEL (CUSTOM) EUDAMED
- Device Name
- Restorative Composite EUDAMED
- Model / Reference
- 101-0016-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D73510100160010 EUDAMED
- Basic UDI-DI
- ++D735CompositeP6 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Category: Dental composite resin
Alpha-Dent Light Cure Hybrid Composite 4 Syringe Kit W/ Etchant Gel (custom) by Dental Technologies, Inc. — Class IIa — MDR — listed in EUDAMED
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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 | ++D735CompositeP6 | 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 (1)
- EUDAMED 70800707-006e-4770-b46c-e097a9a2e8c6 61 fields · synced Jun 19, 2026