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Conical/Concave/Hexagonal system prosthetics - Short Term abutments - Transfers
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref CO/CS/MPN/MPR/MPW/CT/MU/MX/MPW
Identity
- Device Name
- Conical/Concave/Hexagonal system prosthetics - Short Term abutments - Transfers EUDAMED
- Model / Reference
- CO/CS/MPN/MPR/MPW/CT/MU/MX/MPW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290114710695 EUDAMED
- Basic UDI-DI
- B-07290114710695 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental appliance fabrication material, ceramic
Conical/Concave/Hexagonal system prosthetics - Short Term abutments - Transfers by Cortex Dental Implants Industries Ltd. — Class I — FDA_510K, MDD — listed…
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K090709 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K163385 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07290114710695 | Class I | Active |
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Manufacturer
- Manufacturer
- Cortex Dental Implants Industries Ltd.
- EUDAMED SRN
- IL-MF-000010778
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0b5d0e2c-d2bf-4204-90a8-cd0c8618cefb 61 fields · synced Oct 6, 2026
- FDA 510(k) K090709 1 fields · synced May 18, 2026