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Scaler system, periodontic, ultrasonic - ARTG 191161

Access comprehensive regulatory information for Scaler system, periodontic, ultrasonic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 191161 and sponsored by William Green Pty Ltd, manufactured by Bonart Co Ltd in Taiwan. The device registration started on October 28, 2011.

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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Class IIa
ARTG 191161
Class IIa
Scaler system, periodontic, ultrasonic
ARTG ID: 191161
Good Name: William Green Pty Ltd - Scaler system, periodontic, ultrasonic
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Intended Purpose

This is an ultrasonic scaler sytem that is collection of devices using ultrasonic energy in a vibrating tip for the removal of accretions from tooth surfaces during oral prophylaxis and periodontal therapy. This device is intended to be used for oral hygiene and periodontal debridement, e.g., removal of plaque, biofilm, and gross calculus from shallow to deep periodontal pockets. It can also be used for the removal of orthodontic cement.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
191161
Start Date
October 28, 2011
Effective Date
October 28, 2011
Manufacturer
Country
Taiwan
Address
4F-11/3 Wuchuan 1st Road, HSINCHUANG, TAIPEI HSIEN