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Prime-Dent Visible Light Cure Flowable Composite
EUDAMEDClass IIa (EU MDR)
Ref 004-101B2
Identity
- Trade Name
- Prime-Dent Visible Light Cure Flowable Composite EUDAMED
- Device Name
- Prime-Dent Visible Light Cure Flowable Composite EUDAMED
- Model / Reference
- 004-101B2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817441020579 EUDAMED
- Basic UDI-DI
- B-00817441020579 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Prime-Dent Visible Light Cure Flowable Composite by Prime Dental Manufacturing — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00817441020579 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Prime Dental Manufacturing
- EUDAMED SRN
- US-MF-000008807
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 37ab1ad0-be84-45aa-b693-2f51a567fe20 61 fields · synced Sep 30, 2026