Pure Global

Dental occlusal splint, custom-made

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 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Dental occlusal splint, custom-made
Australia TGA ARTG Registered Device
Good Name: Dental Axess Pty Ltd - Dental occlusal splint, custom-made
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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).

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 01, 2022
Effective Date
March 01, 2022
Manufacturer
Country
Canada
Address
9105 rue John-Simons, Quebec City, Province of Quebec, G2B 0S6