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Prime-Dent Prime-Dent Automix Dual Cure Core Build-Up Material
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 003-082 Model TF05510(k) K022675
Identity
- Trade Name
- Prime-Dent Prime-Dent Automix Dual Cure Core Build-Up Material EUDAMED
- Device Name
- Dental Core Build Up Materials EUDAMED
- Model / Reference
- TF05 EUDAMED003-082 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817441026052 EUDAMED
- Basic UDI-DI
- 081744102TF055D EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES 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 Prime-Dent Automix Dual Cure Core Build-Up Material by Prime Dental Manufacturing — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K022675 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 081744102TF055D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Prime Dental Manufacturing
- EUDAMED SRN
- US-MF-000008807
- FDA Applicant
- Prime Dental Manufacturing, Inc.
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 28a2e4d2-6f90-40ce-a54b-2ee54dfe4a87 85 fields · synced Jun 19, 2026
- FDA 510(k) K022675 1 fields · synced May 18, 2026