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Dental Implants -biphasic
EUDAMEDClass IIb (EU MDR)
Ref KCL 1310FX3Model DENTAL IMPLANTS -BIPHASIC
Identity
- Device Name
- DENTAL IMPLANTS -BIPHASIC EUDAMED
- Model / Reference
- DENTAL IMPLANTS -BIPHASIC EUDAMEDKCL 1310FX3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059571004537 EUDAMED
- Basic UDI-DI
- 805957100IMPIANTI63 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Dental Implants -biphasic by ZIACOM ITS S.r.l. — Class IIb — 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 | 805957100IMPIANTI63 | Class IIb | Active |
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Manufacturer
- Manufacturer
- ZIACOM ITS S.r.l.
- EUDAMED SRN
- IT-MF-000028897
Sources (1)
- EUDAMED 5ef5882c-e9cb-408b-be0f-1ad39cf7c598 61 fields · synced Jul 30, 2026