Pure Global

Manual dental scaler, reusable

Access comprehensive regulatory information for Manual dental scaler, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by W9 Pty Ltd, manufactured by PDT Inc in United States of America. The device registration started on July 23, 2024.

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 I
Class I
Manual dental scaler, reusable
Australia TGA ARTG Registered Device
Good Name: W9 Pty Ltd - Manual dental scaler, reusable
Pure Global
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Intended Purpose

A hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 23, 2024
Effective Date
July 23, 2024
Sponsor
Manufacturer
Country
United States of America
Address
8275 Highway 10 West, Missoula, MT, 59808