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ALPHA-DENT, ONE-STEP BRACKET ADHESIVE 3.5g SYRINGE, REFILL
EUDAMEDClass IIa (EU MDR)
Ref 301-0104-001
Identity
- Trade Name
- ALPHA-DENT, ONE-STEP BRACKET ADHESIVE 3.5g SYRINGE, REFILL EUDAMED
- Device Name
- Orthodontic Adhesive EUDAMED
- Model / Reference
- 301-0104-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D73530101040010 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, ONE-STEP BRACKET ADHESIVE 3.5g SYRINGE, REFILL 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 ae4a355d-4005-41e0-aa42-6b8c8c2dbbb1 61 fields · synced Jul 8, 2026