Australia TGA ARTG record

Orthodontic appliance system, progressive

Australia TGA ARTG Registered Device · KD & A Pty Ltd · Access Dental Lab · Class IIa · Started August 02, 2023

Good Name: KD & A Pty Ltd - Orthodontic appliance system, progressive

Device classification

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

Registration information

Start Date: August 02, 2023
Effective Date: August 02, 2023

Sponsor

Name: KD & A Pty Ltd

Manufacturer

Name: Access Dental Lab
Country: United States of America
Address: 1530 Antioch Pike, Antioch, Tennessee, 37013

Intended purpose

SmileDirectClub Aligners are intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion

About this record

Access comprehensive regulatory information for Orthodontic appliance system, progressive in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by KD & A Pty Ltd, manufactured by Access Dental Lab in United States of America. The device registration started on August 02, 2023.

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.