BC4L

Organization name

ROKO SP. Z O.O.

SRN

PL-MF-000050171

Manufacturer status

Active

Primary placement in Poland; available across 1 country total.

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

Trade name

not provided

UDI-DI code

05901421261016

Basic UDI-DI

B-05901421261016

Reference / catalog number

BC4L

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

BIOCETAL is a material for the production of metal-free skeletal dentures. Thanks to its unique, regular and molecular structure, it has excellent physicochemical features. That means the material has dimensional stability, a low abrasion, a resistance to cyclic stress and a biotolerance. The optimal combination of stiffness and resilience as well as a mechanical strength predispose this modern technopolymer to the production of skeletal dentures and individual retention elements. The ideal chemical purity of BIOCETAL 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.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

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