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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Reference AB facebow Set complete — Class I MDR

MD Atlas
"Gamma" Medizinisch-wissenschaftliche Fortbildungs GmbH

EUDAMED last updated this device on Mar 3, 2025

Reference AB facebow Set complete

912012191FBANAVJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: "Gamma" Medizinisch-wissenschaftliche Fortbildungs GmbH
UDI-DI code: 09120121910284
Reference / catalog number: 06-230990

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Manufacturer information

Organization name: "Gamma" Medizinisch-wissenschaftliche Fortbildungs GmbH
SRN: AT-MF-000004222
Manufacturer status: Active

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08-00G200912012191CADIAXSWOn the market 08-SP0250912012191CADIAXSWOn the market 01-10D200-2912012191CADIAXSWOn the market 01-SP0065912012191CADIAXSWOn the market 07-10D200-2912012191CADIAXSWOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement		Still on market

Device identification

Trade name: Reference AB facebow Set complete
UDI-DI code: 09120121910284
Basic UDI-DI: 912012191FBANAVJ
Reference / catalog number: 06-230990
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Die Gesichtsbögen des Reference-Systems dienen zwei Zwecken. Zum einen sind sie notwendiges Zubehör zum CADIAX System. An den Gesichtsbögen werden die Flaggen und Styli des CADIAX befestigt. Zum anderen wird mit den Gesichtsbögen die Kieferrelationsbestimmung, d.h. die Bestimmung der Lage der Kiefer zu einer Referenzebene, durchgeführt. Diese Kieferrelationsbestimmung ist für eine lagegerechte Montage der Kiefermodelle im Artikulator erforderlich.
Additional information URL: https://www.gammadental.com/de/downloads.html
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010401ORTHODONTIC FACE BOWS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification