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Ultrasonic dental scaling/debridement system - Scaler system, periodontic, ultrasonic

Access comprehensive regulatory information for Ultrasonic dental scaling/debridement system - Scaler system, periodontic, ultrasonic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Impetus Dental & Medical, manufactured by Guilin Refine Medical Instrument Co Ltd in China. The device registration started on July 24, 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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Class IIa
Class IIa
Ultrasonic dental scaling/debridement system - Scaler system, periodontic, ultrasonic
Australia TGA ARTG Registered Device
Good Name: Impetus Dental & Medical - Ultrasonic dental scaling/debridement system - Scaler system, periodontic, ultrasonic
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Intended Purpose

Ultrasonic dental scaling/debridement system An assembly of electricity-powered devices intended to apply ultrasonic oscillations to mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or remove accretions from tooth surfaces during dental cleaning/periodontal/prophylaxis therapy.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
July 24, 2024
Effective Date
July 24, 2024
Manufacturer
Country
China
Address
No 8-3 Information Industry Park High-Tech Zone Qixing District Guilin, Guangxi, 541004