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Organization name
UDI-DI code
Reference / catalog number

OrthoPreventAligner® deep bite W — Class I MDR

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

EUDAMED last updated this device on Jan 29, 2024

OrthoPreventAligner® deep bite 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: 04260620320605
Reference / catalog number: 90961

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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® deep bite W
UDI-DI code: 04260620320605
Basic UDI-DI: 4260620320044P
Reference / catalog number: 90961
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® DB-W hard is a training device made of elastic silicone (shore hardness 70) with a reinforced bite block for mixed dentition. It is used for lifting pronounced deep overbites and traumatic sink bite. With this OrthoPreventAligner® DB-W, the lip shield for the upper jaw is steeper to allow the upper incisors, which are usually inclined towards the palate, to straighten. In addition, only the incisors bite down on the appliance, creating a blocking effect in the posterior region. The effect of the OrthoPreventAligner® DB-W is indirect due to this blocking. It stimulates the vertical growth of the posterior teeth according to the bite elevation principle of functional orthodontic appliances (activator, bionator, function regulator, etc.). Since teeth want to lengthen throughout their life until they meet resistance, this treatment can be expected to increase the bite and reduce overbite in incisors. Incl. storage box and user manual
Additional information URL: https://www.dr-hinz-dental.de/shop/de/orthopreventaligner-db-w-90961?q=90961
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

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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.