ONIRIS PLUS

Organization name

oniris

SRN

FR-MF-000014182

Manufacturer status

Active

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• CW999

  ONIRIS MAD (mandibular advancement device) is not suitable for persons who suffer from tooth mobility, disease or infectious complications of the gum or periodontium; people suffering from snoring of nasal origin; people with an uncontrollable gag reflex; people suffering from epilepsy; people undergoing orthodontic treatment; people aged less than 18 years; people who have less than 8 natural teeth per jaw (4 on each side), except for those who have a complete removable denture on the upper jaw or a complete denture attached to 2 Locator-type implants on the lower jaw. This also applies if you still have a wire behind your teeth after orthodontic treatment or if you have veneers. In case of doubt, imperatively consult a dental or ENT specialist.

Primary placement in Bulgaria; available across 9 countries total.

Trade name

ONIRIS PLUS

UDI-DI code

03665389000378

Basic UDI-DI

3665389ONIRIS8X

Reference / catalog number

ONIPLUSIET1

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Oniris is a mandibular advancement splint which repositions the lower jaw slightly forward, thereby freeing the respiratory pathway. Snoring and apnea are thus reduced or eliminated.

Additional information URL

https://www.oniris-ronflement.fr/comment-ca-marche/mode-emploi/

Clinical sizes

No clinical sizes registered for this device.

• Q03010299ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER

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