Australia TGA ARTG recordDental occlusal splint, custom-made
Australia TGA ARTG Registered Device · Smileflex · Smileflex · Class I · Started September 03, 2021
Good Name: Smileflex - Dental occlusal splint, custom-made
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- September 03, 2021
- Effective Date
- September 03, 2021
- Name
- Smileflex
- Name
- Smileflex
- Country
- Australia
- Address
- 236/416 St Kilda Road, Melbourne, VIC, 3004
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.
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 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.