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Prime-Dent Light Cure Micro-Hybrid Composite
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 001-414
Identity
- Trade Name
- Prime-Dent Light Cure Micro-Hybrid Composite EUDAMEDPrime Dent Visible Light Cure Micro Hybrid Composite FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- VLC Micro-Hybrid Composite 4 Syringe Kit EUDAMEDPrime Dent Visible Light Cure Micro Hybrid Composite - 4 syringe KIT FDA UDI
- Model / Reference
- 001-414 EUDAMEDFDA UDI
- Description
- Prime Dent Visible Light Cure Micro Hybrid Composite - 4 syringe KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817441020999 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817441020999 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
Prime-Dent Light Cure Micro-Hybrid Composite by Prime Dental Manufacturing — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00817441020999 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Prime Dental Manufacturing
- EUDAMED SRN
- US-MF-000008807
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e0d9ce8a-8137-463e-b0c2-c9f1e3a8e35f 61 fields · synced Jul 11, 2026
- FDA UDI 87481d41-a583-4672-89ef-ebd57d71dbd3 33 fields · synced May 30, 2026