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Dental impression material kit, single-use

Australia TGA ARTG Registered Device · byte Au Unit Trust · Straight Smile LLC dba Byte · Class I · Started August 01, 2022

Good Name: byte Au Unit Trust - Dental impression material kit, single-use

Device classification
Risk Class
Class I
Product Type
Procedure Pack
ARTG Category
General
Registration information
Start Date
August 01, 2022
Effective Date
August 01, 2022
Sponsor
Manufacturer
Country
United States of America
Address
1556 20th St Ste A, Santa Monica, CA, 90404
Intended purpose

A collection of non-sterile devices intended for a single patient use to attain an imprint of upper and lower teeth (including gums) for the construction of mould to manufacturer a custom-made orthodontic appliance. The kit includes dental impression materials, dental trays, gloves (optional), and cheek expander (optional)

About this record

Access comprehensive regulatory information for Dental impression material kit, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by byte Au Unit Trust, manufactured by Straight Smile LLC dba Byte in United States of America. The device registration started on August 01, 2022.

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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