Identity
- Trade Name
- Prime-Dent Hema Desensitizer EUDAMED
- Device Name
- Prime-Dent Hema Desensitizer EUDAMED
- Model / Reference
- 018-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817441022757 EUDAMED
- Basic UDI-DI
- B-00817441022757 EUDAMED
- EMDN Code
- Q019008 DENTINAL DESENSITISERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prime-Dent Hema Desensitizer by Prime Dental Manufacturing — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013970 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-00817441022757 | Class III | Active |
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Manufacturer
- Manufacturer
- Prime Dental Manufacturing
- EUDAMED SRN
- US-MF-000008807
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED b4971bbe-734b-4d74-9977-6a3b1802cbb0 61 fields · synced Jul 23, 2026
- FDA 510(k) K013970 1 fields · synced May 18, 2026