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Planmeca's Panoramic Digital X-Ray system - ProMax/ProOne - Stationary panoramic dental x-ray system, digital

Access comprehensive regulatory information for Planmeca's Panoramic Digital X-Ray system - ProMax/ProOne - Stationary panoramic dental x-ray system, digital in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Henry Schein Halas, manufactured by Planmeca Oy in Finland. The device registration started on August 19, 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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Class IIb
Class IIb
Planmeca's Panoramic Digital X-Ray system - ProMax/ProOne - Stationary panoramic dental x-ray system, digital
Australia TGA ARTG Registered Device
Good Name: Henry Schein Halas - Planmeca's Panoramic Digital X-Ray system - ProMax/ProOne - Stationary panoramic dental x-ray system, digital
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Intended Purpose

These diagnostic extra-oral radiation apparatus helps produce superior quality two-dimensional (2D) X-ray images for the examination of dentomaxillofacial anatomy, implying the human dentition, maxilla, mandible, our temporomandibular joints etc (panoramic or wide field of view) and is operated/used by the dentists and other qualified professionals.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
August 19, 2021
Effective Date
August 19, 2021
Manufacturer
Country
Finland
Address
Asentajankatu 6, Helsinki, 00880