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R.T.R.+ 40/60 - Bone matrix implant, synthetic - ARTG 373570

Access comprehensive regulatory information for R.T.R.+ 40/60 - Bone matrix implant, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 373570 and sponsored by Specialites Septodont Pty Ltd, manufactured by Biomatlante SA ZA les Quatre Nations in France. The device registration started on August 26, 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 III
ARTG 373570
Class III
R.T.R.+ 40/60 - Bone matrix implant, synthetic
ARTG ID: 373570
Good Name: Specialites Septodont Pty Ltd - R.T.R.+ 40/60 - Bone matrix implant, synthetic
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Intended Purpose

The Synthetic Bone Substitute is intended for use to reconstruct bony voids or bone gaps in particular in maxillofacial applications: - Periodontal/Intrabony defects filling - Ridge augmentation - Implant preparation, placement in extraction sites - Sinus lifts - Cystic cavities filling The performances of the Synthetic Bone Substitute are the filling of bone defects and the bony ingrowth from local osseous tissue onto the surface of the product (osteoconduction process). The total resorption of the product depends on numerous factors such as its size and volume, the location of the defect, the surgical technique, the health status of the patient. The bone reconstruction time is always inferior to the total resorption time.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
373570
Start Date
August 26, 2021
Effective Date
August 26, 2021
Manufacturer
Country
France
Address
5 Rue Edouard Belin, Vigneux De Bretagne, 44360