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ALPHA II AP, LIGHT CURE MICRO-HYBRID COMPOSITE, 4.5g SYRINGE - A3
EUDAMEDClass IIa (EU MDR)
Ref 102-0301-002Ref 102-0101-002Ref 102-0201-002Ref 102-0401-002
Identity
- Trade Name
- ALPHA II AP, LIGHT CURE MICRO-HYBRID COMPOSITE, 4.5g SYRINGE - A3 EUDAMEDALPHA II AP, LIGHT CURE MICRO-HYBRID COMPOSITE, 4.5g SYRINGE - A1 EUDAMEDALPHA II AP, LIGHT CURE MICRO-HYBRID COMPOSITE, 4.5g SYRINGE- A2 EUDAMEDALPHA II AP, MICRO-HYBRID COMPOSITE, 4.5g SYRINGE - A3.5 EUDAMED
- Device Name
- Restorative Composite EUDAMED
- Model / Reference
- 102-0301-002 EUDAMED102-0101-002 EUDAMED102-0201-002 EUDAMED102-0401-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D73510203010020 EUDAMED+D73510201010020 EUDAMED+D73510202010020 EUDAMED+D73510204010020 EUDAMED
- Basic UDI-DI
- ++D735CompositeP6 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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 II AP, LIGHT CURE MICRO-HYBRID COMPOSITE, 4.5g SYRINGE - A3 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 (4)
- EUDAMED 33c06a18-b658-46f7-9e26-a47623d25a2b 61 fields · synced Jul 25, 2026
- EUDAMED 6f6cb224-18b2-4594-9120-223f3103deea 61 fields · synced May 16, 2026
- EUDAMED c82d8788-79a8-4f86-912c-2640080a55f5 61 fields · synced May 17, 2026
- EUDAMED 6af9fd7f-3aab-41d1-a06b-52a40ee2ec35 61 fields · synced May 18, 2026