Pure Global

Dental occlusal splint, custom-made - ARTG 328037

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 registered under ARTG number 328037 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 328037
Class IIa
Dental occlusal splint, custom-made
ARTG ID: 328037
Good Name: Ultimate Dental Supplies - Dental occlusal splint, custom-made
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
328037
Start Date
December 23, 2019
Effective Date
December 23, 2019
Manufacturer
Country
United States of America
Address
Unit G 815 Oakwood Road, Lake Zurich, Illinois, 60047