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Organization name
UDI-DI code
Reference / catalog number

OrthoPreventAligner® open bite… — Class I MDR

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

EUDAMED last updated this device on Jan 29, 2024

OrthoPreventAligner® open bite M-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: 04260620320506
Reference / catalog number: 90911

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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.

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

Device identification

Trade name: OrthoPreventAligner® open bite M-soft
UDI-DI code: 04260620320506
Basic UDI-DI: 4260620320044P
Reference / catalog number: 90911
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® OB-M soft is a training device made of highly elastic silicone (shore hardness 45) for the primary dentition. It helps to break harmful sucking habits and other malfunctions of the oral musculature. The elimination of the open bite is initially indirect: the tongue is prevented from being permanently placed between the incisors. In addition, there is a direct effect by resting the elongated and strongly backward inclined upper lip shield on the usually protruding and shortened teeth, which are thus directed toward the palate. This allows the teeth to lengthen again in a self-regulating manner. By closing the open bite, the defective phonation is corrected, pronunciation is improved and biting with the incisors becomes possible again. Incl. storage box and user manual
Additional information URL: https://www.dr-hinz-dental.de/shop/de/orthopreventaligner-ob-m-soft-90911?q=OrthoPreventAligner%C2%AE+OB-M++soft
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
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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.