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 Prosharp Dental, manufactured by Melpex Beauty Instruments in Pakistan. The device registration started on April 21, 2021.

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: Prosharp Dental - 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. It is typically designed as a one-piece instrument with a pointed, angled or curved distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 21, 2021
Effective Date
April 21, 2021
Sponsor
Manufacturer
Country
Pakistan
Address
Rangers HQ Road Cantt Langeriali, Sialkot, Punjab, 51310