Australia TGA ARTG record

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

Australia TGA ARTG Registered Device · Henry Schein Halas · Planmeca Oy · Class IIb · Started August 19, 2021

Good Name: Henry Schein Halas - Planmeca's Panoramic Digital X-Ray system - ProMax/ProOne - Stationary panoramic dental x-ray system, digital

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

Sponsor

Name: Henry Schein Halas

Manufacturer

Name: Planmeca Oy
Country: Finland
Address: Asentajankatu 6, Helsinki, 00880

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.

About this record

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.