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Organization name
UDI-DI code
Reference / catalog number

Silasto® 50 — Class I MDR by Dr. Hinz Dental-Vertrieb…

MD Atlas
Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG

EUDAMED last updated this device on Jan 31, 2024

Silasto® 50

4260620320084X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG
UDI-DI code: 04260620320995
Reference / catalog number: 97402

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Manufacturer information

Organization name: Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG
SRN: DE-MF-000006965
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: Silasto® 50
UDI-DI code: 04260620320995
Basic UDI-DI: 4260620320084X
Reference / catalog number: 97402
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: Successful treatment with the ELASTO orthodontic system requires a silicone based material with a high level of resilience in case of biologically tenable forces, sustainedpermanent elasticity, high tensile strength, stable transparency, neutral taste and odour and disinfecting ability. These requirementsare met by the silicone material SILASTO® 50. The catalytic system is characterised by high biocompatibility, which makes the material SILASTO® physiologically safe to use SILASTO® is further processed using the cuvette technology known from prosthetics. The contents of the dual chamber cartridge are sufficient for at least one SILASTO® device.
Additional information URL: https://www.dr-hinz-dental.de/shop/de/silasto-50-set-5-doppelkartuschen-a-50-ml-97402?q=97402
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010499ORTHODONTIC 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.