Pure Global

Dental occlusal splint, custom-made - ARTG 374136

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 374136 and sponsored by Smileflex, manufactured by Smileflex in Australia. The device registration started on September 03, 2021.

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 374136
Class I
Dental occlusal splint, custom-made
ARTG ID: 374136
Good Name: Smileflex - Dental occlusal splint, custom-made
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Intended Purpose

A patient-matched device intended to overlay the occlusal surfaces of the teeth to treat teeth clenching and bruxism, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain. It is typically made of synthetic polymer materials. This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
374136
Start Date
September 03, 2021
Effective Date
September 03, 2021
Sponsor
Manufacturer
Country
Australia
Address
236/416 St Kilda Road, Melbourne, VIC, 3004