Intraoral camera - ARTG 400573
Access comprehensive regulatory information for Intraoral camera in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 400573 and sponsored by Henry Schein Halas, manufactured by Planmeca Oy in Finland. The device registration started on December 05, 2022.
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.
It is an active optical device used to record the topographical characteristics of the dentition and/or full arch and preparation areas (including features such as implant scan locator fixtures, braces, brackets, etc.). In addition, it can record the topographical characteristics of the oral anatomy (such as soft tissue, gingivae, and palate). The three-dimensional model generated from the scan may be further used for study models, and for the design and manufacturing of dental restorations including implant supported prosthesis and full and partial frameworks and can be used to design and manufacture of physical models of the teeth. It may be used in conjunction with production of orthodontic appliances, retainer, and accessories. It also helps as an aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.