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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

10004100 — Class IIa MDR by OCO-Präparate…

MD Atlas
OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH

EUDAMED last updated this device on Mar 29, 2024

10004100

426074131-CALXYL-OCO-B9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH
UDI-DI code: 04260741310080
Reference / catalog number: 10004100

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Manufacturer information

Organization name: OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH
SRN: DE-MF-000012362
Manufacturer status: Active

Related devices

10001100 426074131-CALXYL-OCO-B9On the market 10000100426074131-CALXYL-OCO-B9On the market 10000200426074131-CALXYL-OCO-B9On the market 10001200426074131-CALXYL-OCO-B9On the market 10001900426074131-CALXYL-OCO-B9On the market

Critical warnings

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

CW010
Avoid eye contact

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jun 15, 2013	Still on market
France	Jun 15, 2015	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260741310080
Basic UDI-DI: 426074131-CALXYL-OCO-B9
Reference / catalog number: 10004100
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Pastenförmige Suspension zur Versorgung des kariesfreien pulpennahen Dentins, Caries profunda Behandlun, indirekte und direkte Pulpenüberkappung, Pulpotomie und als Einlage in den Wurzelkanal.
Additional information URL: https://www.oco-praeparate.de/de/p/calxyl_dentin_10/
Clinical sizes: 1.5 MU03

EMDN nomenclature code(s)

Q01010201ROOT CANAL FILLING DENTAL PASTES

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

Batch number
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Software identification

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.