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ALPHA II AP, LIGHT CURE MICRO-HYBRID COMPOSITE, 15 x.30g UNIT-DOSE REFILLS - A1
EUDAMEDClass IIa (EU MDR)
Ref 102-0102-002Ref 102-0302-002
Identity
- Trade Name
- ALPHA II AP, LIGHT CURE MICRO-HYBRID COMPOSITE, 15 x.30g UNIT-DOSE REFILLS - A1 EUDAMEDALPHA II AP, LIGHT CURE MICRO-HYBRID COMPOSITE, 15 x.30g UNIT-DOSE REFILLS - A3 EUDAMED
- Device Name
- Restorative Composite EUDAMED
- Model / Reference
- 102-0102-002 EUDAMED102-0302-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D73510201020020 EUDAMED+D73510203020020 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, 15 x.30g UNIT-DOSE REFILLS - A1 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 (2)
- EUDAMED e66505c6-a720-48b4-b0e5-3a9196eb63d0 61 fields · synced Jul 24, 2026
- EUDAMED e84f08bd-8dcc-4f7a-8989-3e2a8a1c2ecb 61 fields · synced May 18, 2026