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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

DCL — Class I MDD by ROKO SP. Z O.O.

MD Atlas
ROKO SP. Z O.O.

EUDAMED last updated this device on Jan 20, 2026

DCL

B-05901421260200

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ROKO SP. Z O.O.
UDI-DI code: 05901421260200
Reference / catalog number: DCL

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View device family (Basic UDI)

Manufacturer information

Organization name: ROKO SP. Z O.O.
SRN: PL-MF-000050171
Manufacturer status: Active

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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

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 05901421260200
Basic UDI-DI: B-05901421260200
Reference / catalog number: DCL
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: DENTIFLEX is a modern polyamide material designed for the production of aesthetic partial dentures. It allows the complete elimination of metal retention elements from partial settling and skeletal dentures. The exceptional flexibility of the material makes it possible to make aesthetic and practically invisible elements that hold the denture. The ideal chemical purity of DENTIFLEX (polyamide N 120M) makes it a fully biocompatible material. Its neutral effect on the patient's health is confirmed by the certificates of the National Institute of Medicines.
Additional information URL: https://rokodent.pl/termoplasty/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER

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

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