Pure Global

Dental impression material kit, single-use - ARTG 393170

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 registered under ARTG number 393170 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 393170
Class I
Dental impression material kit, single-use
ARTG ID: 393170
Good Name: byte Au Unit Trust - Dental impression material kit, single-use
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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)

Device Classification
Risk Class
Class I
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
393170
Start Date
August 01, 2022
Effective Date
August 01, 2022
Manufacturer
Country
United States of America
Address
1556 20th St Ste A, Santa Monica, CA, 90404