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Implant prosthetic components
EUDAMEDClass IIb (EU MDR)
Ref KUHP 5000Model Implant prosthetic components
Identity
- Device Name
- Implant prosthetic components EUDAMED
- Model / Reference
- Implant prosthetic components EUDAMEDKUHP 5000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059571005848 EUDAMED
- Basic UDI-DI
- 805957100PROTESICL.2MS EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Category: Dental implant suprastructure, temporary, preformed, single-use
Implant prosthetic components by ZIACOM ITS S.r.l. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
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- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
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 | 805957100PROTESICL.2MS | Class IIb | Active |
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Manufacturer
- Manufacturer
- ZIACOM ITS S.r.l.
- EUDAMED SRN
- IT-MF-000028897
Sources (1)
- EUDAMED aaea5bad-1b5a-4b34-a523-686015e983ae 61 fields · synced Jul 13, 2026