Pure Global

Orthodontic appliance, retainer

Access comprehensive regulatory information for Orthodontic appliance, retainer 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 July 28, 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.

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TGA ARTG Official Data
Class IIa
Class IIa
Orthodontic appliance, retainer
Australia TGA ARTG Registered Device
Good Name: KD & A Pty Ltd - Orthodontic appliance, retainer
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Intended Purpose

SmileDirectClub Retainer is intended to hold the teeth in position after tooth alignment

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 28, 2023
Effective Date
July 28, 2023
Sponsor
Manufacturer
Country
United States of America
Address
1530 Antioch Pike, Antioch, Tennessee, 37013