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Mandible-repositioning antisnoring orthosis - ARTG 383890

Access comprehensive regulatory information for Mandible-repositioning antisnoring orthosis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 383890 and sponsored by Dental Axess Pty Ltd, manufactured by Panthera Dental Inc in Canada. The device registration started on February 11, 2022.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class I
ARTG 383890
Class I
Mandible-repositioning antisnoring orthosis
ARTG ID: 383890
Good Name: Dental Axess Pty Ltd - Mandible-repositioning antisnoring orthosis
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Intended Purpose

Panthera D-Sad: This is a removable intra-oral device that is intended to be used to prevent snoring and/or obstructive sleep apnoea by repositioning the lower jaw (mandible), frequently in a downward and forward position.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
383890
Start Date
February 11, 2022
Effective Date
February 11, 2022
Manufacturer
Country
Canada
Address
9105 rue John-Simons, Quebec City, Province of Quebec, G2B 0S6