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Organization name
UDI-DI code
Reference / catalog number

OrthoPreventAligner® prevention… — Class I MDR

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

EUDAMED last updated this device on Jan 29, 2024

OrthoPreventAligner® prevention W-soft

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: 04260620320544
Reference / catalog number: 90931

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Manufacturer information

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

Related devices

Friedensstifter class I4260620320074VOn the market OrthoPreventAligner® prevention W-hard4260620320044POn the market BRUXI+, set4260620320034MOn the market BRUXI+, single4260620320034MOn the market Friedensstifter class II4260620320074VOn the market

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® prevention W-soft
UDI-DI code: 04260620320544
Basic UDI-DI: 4260620320044P
Reference / catalog number: 90931
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® PR-W soft is a training device made of highly elastic silicone (shore hardness 45) for the mixed dentition. It helps to break harmful sucking habits and other malfunctions of the oral musculature. The restoring force of the material can correct harmful habits and dysfunctions, such as an open mouth posture, harmful mouth breathing and postural weaknesses of the oral musculature. The OrthoPreventAligner® PR shields the interfering soft tissues (tongue, buccal mucosa) and activates the mouth and lip muscles. It has an ideal semi-circular shape into which teeth standing outside the dental arch can be placed by the restoring force of the silicone. In order to achieve healthy nasal breathing in the case of existing mouth breathing, the device deliberately closes the mouth without air slits. Including mounting box and user manual
Additional information URL: https://www.dr-hinz-dental.de/shop/de/orthopreventaligner-pr-w-soft-90931?q=90931
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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