← Back to catalogue
ALPHA-DENT, ONE-STEP BRACKET ADHESIVE UNIT-DOSE (40 x.35g), REFILL
EUDAMEDClass IIa (EU MDR)
Ref 301-0102-001
Identity
- Trade Name
- ALPHA-DENT, ONE-STEP BRACKET ADHESIVE UNIT-DOSE (40 x.35g), REFILL EUDAMED
- Device Name
- Orthodontic Adhesive EUDAMED
- Model / Reference
- 301-0102-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D73530101020010 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 UNIT-DOSE (40 x.35g), REFILL by Dental Technologies, Inc. — Class IIa — MDR — listed in EUDAMED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dental Technologies, Inc.
- EUDAMED SRN
- US-MF-000027130
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED bbe42df6-2f7d-4c74-bcde-a8b4e6018316 61 fields · synced Jun 18, 2026