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ALPHA II AP, MICRO-HYBRID COMPOSITE, 4.5g SYRINGE - INCISAL
EUDAMEDClass IIa (EU MDR)
Ref 102-1901-002
Identity
- Trade Name
- ALPHA II AP, MICRO-HYBRID COMPOSITE, 4.5g SYRINGE - INCISAL EUDAMED
- Device Name
- Restorative Composite EUDAMED
- Model / Reference
- 102-1901-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D73510219010020 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
ALPHA II AP, MICRO-HYBRID COMPOSITE, 4.5g SYRINGE - INCISAL 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 | ++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 eef90bf4-1524-4745-a5a9-f5a0bd0e46b4 61 fields · synced Oct 6, 2026