Identity
- Device Name
- Hex Saturn Implants EUDAMED
- Model / Reference
- BST-xxxx EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290112781192 EUDAMED
- Basic UDI-DI
- B-07290112781192 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hex Saturn Implants by Cortex Dental Implants Industries Ltd. — Class IIb — 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 | K131258 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-07290112781192 | Class IIb | 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 dc18ad0b-10ef-4fbd-b943-603c456afdea 61 fields · synced Oct 6, 2026
- FDA 510(k) K131258 1 fields · synced May 18, 2026