Australia TGA ARTG record

Dental occlusal splint, custom-made

Australia TGA ARTG Registered Device · Ultimate Dental Supplies · Astron Dental Corporation · Class IIa · Started December 23, 2019

Good Name: Ultimate Dental Supplies - Dental occlusal splint, custom-made

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 23, 2019
Effective Date: December 23, 2019

Sponsor

Name: Ultimate Dental Supplies

Manufacturer

Name: Astron Dental Corporation
Country: United States of America
Address: Unit G 815 Oakwood Road, Lake Zurich, Illinois, 60047

Intended purpose

Polymer based materials that are intended to fabricate a dental device such as, splints, night guards, grinding splints and retainers.

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 IIa is sponsored by Ultimate Dental Supplies, manufactured by Astron Dental Corporation in United States of America. The device registration started on December 23, 2019.

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.