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Organization name
UDI-DI code
Reference / catalog number

OrthoPreventAligner® lower jaw… — Class I MDR

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

EUDAMED last updated this device on Jan 29, 2024

OrthoPreventAligner® lower jaw retraction Kl II-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: 04260620320582
Reference / catalog number: 90951

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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® lower jaw retraction Kl II-W-soft
UDI-DI code: 04260620320582
Basic UDI-DI: 4260620320044P
Reference / catalog number: 90951
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® KL II soft is a training device made of highly elastic silicone (shore hardness 45) for the mixed dentition. It is intended for the treatment of mandibular recession with elimination of the excessively large incisor step. This tooth misalignment is already caused in the primary dentition by persistent sucking habits. The elimination of the too large anterior tooth step is partially indirect by growth stimulation of the incorrectly posterior lower jaw. This results in the correct position of the lower jaw in relation to the upper jaw. In addition, there is a direct effect by resting the elongated and strongly backward inclined upper jaw lip shield on the incisors, which are usually in a gapped position. They are thus directed palatally, which contributes to the reduction of the incisor step. Eliminating the incisor step also improves pronunciation and facilitates biting with the incisors. Incl. storage box and user manual
Additional information URL: https://www.dr-hinz-dental.de/shop/de/orthopreventaligner-kl-ii-w-soft-90951?q=90951
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
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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.