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ALPHA-DENT LIGHT CURE HYBRID COMPOSITE 4.5g REFILL SYRINGE- A3
EUDAMEDClass IIa (EU MDR)
Ref 101-0301-001Ref 101-0401-001Ref 101-0601-001Ref 101-1201-001Ref 101-0101-001Ref 101-0801-001Ref 101-1401-001
Identity
- Trade Name
- ALPHA-DENT LIGHT CURE HYBRID COMPOSITE 4.5g REFILL SYRINGE- A3 EUDAMEDALPHA-DENT LIGHT CURE HYBRID COMPOSITE 4.5g REFILL SYRINGE- A3.5 EUDAMEDALPHA-DENT LIGHT CURE HYBRID COMPOSITE 4.5g REFILL SYRINGE- B1 EUDAMEDALPHA-DENT LIGHT CURE HYBRID COMPOSITE 4.5g REFILL SYRINGE- C3 EUDAMEDALPHA-DENT LIGHT CURE HYBRID COMPOSITE 4.5g REFILL SYRINGE- A1 EUDAMEDALPHA-DENT LIGHT CURE HYBRID COMPOSITE 4.5g REFILL SYRINGE- B3 EUDAMEDALPHA-DENT LIGHT CURE HYBRID COMPOSITE 4.5g REFILL SYRINGE- D4 EUDAMED
- Device Name
- Restorative Composite EUDAMED
- Model / Reference
- 101-0301-001 EUDAMED101-0401-001 EUDAMED101-0601-001 EUDAMED101-1201-001 EUDAMED101-0101-001 EUDAMED101-0801-001 EUDAMED101-1401-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D73510103010010 EUDAMED+D73510104010010 EUDAMED+D73510106010010 EUDAMED+D73510112010010 EUDAMED+D73510101010010 EUDAMED+D73510108010010 EUDAMED+D73510114010010 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 4.5g REFILL SYRINGE- A3 by Dental Technologies, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 7ab938e9-5054-41ee-a4f7-43fdb5008d70 61 fields · synced Sep 18, 2026
- EUDAMED c295315b-515d-441a-bdfe-2bcbeda4a552 61 fields · synced May 17, 2026
- EUDAMED 6545e69b-1d90-4913-b56f-4b96af9ea893 61 fields · synced May 17, 2026
- EUDAMED 09fbe587-2c31-45c4-98bf-bf105447ff9d 61 fields · synced May 17, 2026
- EUDAMED 807f5a4e-5db1-4d0a-85e2-116d822828a5 61 fields · synced May 18, 2026
- EUDAMED 555909d9-f1d2-4e82-96ee-65caeb28a1ea 61 fields · synced May 18, 2026
- EUDAMED ef9e8ad9-6519-403f-8f00-d492aadd14d8 61 fields · synced May 18, 2026