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Prime-Dent Glass Ionomer Powder/Liquid Cement
EUDAMEDClass IIa (EU MDR)
Ref 010-020
Identity
- Trade Name
- Prime-Dent Glass Ionomer Powder/Liquid Cement EUDAMED
- Device Name
- Glass Ionomer Cement Kit 18 g Powder/17.5ml Liquid EUDAMED
- Model / Reference
- 010-020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817441022115 EUDAMED
- Basic UDI-DI
- 081744102TF0359 EUDAMED
- EMDN Code
- Q0101010201 DENTAL BASE CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Prime-Dent Glass Ionomer Powder/Liquid Cement by Prime Dental Manufacturing — 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 | 081744102TF0359 | 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 8b0f95aa-c6e8-41bf-9004-e5854c2e96ad 61 fields · synced Jul 13, 2026