Australia flagARTG 384905

Dental occlusal splint, custom-made

ARTG ID: 384905 · Dental Axess Pty Ltd · Panthera Dental Inc · Class I · Started March 01, 2022

Good Name: Dental Axess Pty Ltd - Dental occlusal splint, custom-made

Device classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
384905
Start Date
March 01, 2022
Effective Date
March 01, 2022
Sponsor
Manufacturer
Country
Canada
Address
9105 rue John-Simons, Quebec City, Province of Quebec, G2B 0S6
Intended purpose

Panthera Occlusal Appliance: This is a rigid custom-made device that is intended to be used to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction).

About this record

Access comprehensive regulatory information for Dental occlusal splint, custom-made in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 384905 and sponsored by Dental Axess Pty Ltd, manufactured by Panthera Dental Inc in Canada. The device registration started on March 01, 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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