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Sirona CAD/CAM Titanium Base 1.5 IH

EUDAMED

Class IIb (EU MDR)

Ref 5464Model Tibase

by Alpha Bio Tec Ltd.

Identity

Trade Name
Sirona CAD/CAM Titanium Base 1.5 IH EUDAMED
Model / Reference
Tibase EUDAMED
5464 EUDAMED

Identifiers

Primary DI / UDI-DI
07290117813973 EUDAMED
Basic UDI-DI
729011781Tibase5D EUDAMED
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

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

Sirona CAD/CAM Titanium Base 1.5 IH by Alpha Bio Tec Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Alpha Bio Tec Ltd.
EUDAMED SRN
IL-MF-000021145
Authorised Representative
AR Experts B.V. NL-AR-000023989

Sources (1)

  • EUDAMED 683b7dfd-fc62-42de-9a11-f7261a25a18a 61 fields · synced Jun 18, 2026