← Back to catalogue
Prime-Dent Automix Non Eugenol Temporary Cement
EUDAMEDClass IIa (EU MDR)
Ref 023-012Model TF07
Identity
- Trade Name
- Prime-Dent Automix Non Eugenol Temporary Cement EUDAMED
- Device Name
- Dental Temporary Cements EUDAMED
- Model / Reference
- TF07 EUDAMED023-012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817441022160 EUDAMED
- Basic UDI-DI
- 081744102TF075H EUDAMED
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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 Automix Non Eugenol Temporary Cement by Prime Dental Manufacturing — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 081744102TF075H | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prime Dental Manufacturing
- EUDAMED SRN
- US-MF-000008807
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 35a242dc-381f-4dcc-aea1-f215a1bf7141 61 fields · synced Jul 9, 2026