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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

ISTplus®-Set, foils Ø 120 mm — Class I MDR

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

EUDAMED last updated this device on Jan 30, 2024

ISTplus®-Set, foils Ø 120 mm

4260620320054R

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: 04260620320858
Reference / catalog number: 98210

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Manufacturer information

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

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.

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: ISTplus®-Set, foils Ø 120 mm
UDI-DI code: 04260620320858
Basic UDI-DI: 4260620320054R
Reference / catalog number: 98210
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: The ISTplus® device acc. to Prof. Hinz is a further development of the proven IST appliance. This appliance offers maximum wearing comfort with optimal space for ventral placement of the tongue due to its interocclusal guide bars,which are connected from the mandible distally to the maxilla mesially. The ISTplus®-Set contains the ISTplus®-KIT, consisting of two adjustable connecting bars with plastic anchorage and placeholders as well as a safety and Allen key each. In addition, you will receive foils (Ø 120), polymer, monomer, a bite fork and a storage box.
Additional information URL: https://www.dr-hinz-dental.de/shop/de/98210?q=98210
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
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Serial number
Software identification

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