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ALPHA-DENT LIGHT CURE HYBRID COMPOSITE 15 X .30 g UNIT DOSE REFILL - A3.5
EUDAMEDClass IIa (EU MDR)
Ref 101-0403-001Ref 101-0203-001Ref 101-0703-001Ref 101-0803-001Ref 101-0103-001Ref 101-0303-001Ref 101-0603-001
Identity
- Trade Name
- ALPHA-DENT LIGHT CURE HYBRID COMPOSITE 15 X .30 g UNIT DOSE REFILL - A3.5 EUDAMEDALPHA-DENT LIGHT CURE HYBRID COMPOSITE 15 X .30 g UNIT DOSE REFILL - A2 EUDAMEDALPHA-DENT LIGHT CURE HYBRID COMPOSITE 15 X .30 g UNIT DOSE REFILL - B2 EUDAMEDALPHA-DENT LIGHT CURE HYBRID COMPOSITE 15 X .30 g UNIT DOSE REFILL - B3 EUDAMEDALPHA-DENT LIGHT CURE HYBRID COMPOSITE 15 X .30 g UNIT DOSE REFILL - A1 EUDAMEDALPHA-DENT LIGHT CURE HYBRID COMPOSITE 15 X .30 g UNIT DOSE REFILL - A3 EUDAMEDALPHA-DENT LIGHT CURE HYBRID COMPOSITE 15 X .30 g UNIT DOSE REFILL - B1 EUDAMED
- Device Name
- Restorative Composite EUDAMED
- Model / Reference
- 101-0403-001 EUDAMED101-0203-001 EUDAMED101-0703-001 EUDAMED101-0803-001 EUDAMED101-0103-001 EUDAMED101-0303-001 EUDAMED101-0603-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 101-0403-001 EUDAMED+D73510102030010 EUDAMED+D73510107030010 EUDAMED+D73510108030010 EUDAMED+D73510101030010 EUDAMED+D73510103030010 EUDAMED+D73510106030010 EUDAMED
- Basic UDI-DI
- ++D735CompositeP6 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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-DENT LIGHT CURE HYBRID COMPOSITE 15 X .30 g UNIT DOSE REFILL - A3.5 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 (7)
- EUDAMED dc79ba89-7f58-4c92-80a9-e5ce21eaeb0e 61 fields · synced Aug 2, 2026
- EUDAMED 8cbb4330-7ded-42e0-af6a-b2b131ad25aa 61 fields · synced May 17, 2026
- EUDAMED 42d1bfca-6583-4c02-aa2e-83dfae7d0c08 61 fields · synced May 17, 2026
- EUDAMED 96fb8020-1598-455d-9e10-00b77f3d5849 61 fields · synced May 17, 2026
- EUDAMED 633c8acd-31fd-49af-8487-684a0cb3199f 61 fields · synced May 18, 2026
- EUDAMED d96a95dd-5e9a-4d57-8515-b56766c15b68 61 fields · synced May 18, 2026
- EUDAMED 7b630481-5613-4ba4-b36d-c3291c3b3f9f 61 fields · synced May 18, 2026