Identity
- Trade Name
- ALPHA-DENT PRIMER, 12ml EUDAMED
- Device Name
- Orthodontic Adhesive EUDAMED
- Model / Reference
- 209-0101-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D73520901010010 EUDAMED
- Basic UDI-DI
- ++D735OrthodontAdhesiveBZ EUDAMED
- EMDN Code
- Q010407 ORTHODONTIC CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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-DENT PRIMER, 12ml 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 | ++D735OrthodontAdhesiveBZ | 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 1119812e-99ed-4eb7-8abc-e8da539c1d46 61 fields · synced Jul 27, 2026