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Organization name
UDI-DI code
Reference / catalog number

OrthoPreventAligner® bruxism-W — Class I MDR

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

EUDAMED last updated this device on Jan 29, 2024

OrthoPreventAligner® bruxism-W

4260620320044P

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: 04260620320612
Reference / catalog number: 90971

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Manufacturer information

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

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Aug 1, 2018	Jan 31, 2040

Device identification

Trade name: OrthoPreventAligner® bruxism-W
UDI-DI code: 04260620320612
Basic UDI-DI: 4260620320044P
Reference / catalog number: 90971
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 OrthoPreventAligner® BR is made from a highly elastic silicone (shore hardness 70) that resists the strong chewing pressure that arises from the night-time grinding of teeth. Nocturnal teeth grinding, which frequently occurs in small children, is considered by scientist to be one of the causes and a risk factor for temporomandibular joint and masticatory muscle disorders (craniomandibular dysfunction = CMD) in adults. The OrthoPreventAligner® bruxism prevents grinding and leads to the relief of the jaw joints. The teeth are protected from abrasion and damage to the enamel. If there are other malfunctions caused by the tongue or incorrectly positioned Teeth, these are also corrected with the OrthoPreventAligner® BR. If this OrthoPreventAligner® is exclusively indicated due to bruxism, it is, in contrast to the other versions of the device, only worn at night. Incl. storage box and user manual
Additional information URL: https://www.dr-hinz-dental.de/shop/de/orthopreventaligner-br-w-90971?q=90971
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

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