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Exabone Paste - Graft, bone, synthetic - ARTG 232998

Access comprehensive regulatory information for Exabone Paste - Graft, bone, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 232998 and sponsored by MDSS AU Pty Ltd, manufactured by Exabone GmbH in Switzerland. The device registration started on January 21, 2015.

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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TGA ARTG Official Data
Class III
ARTG 232998
Class III
Exabone Paste - Graft, bone, synthetic
ARTG ID: 232998
Good Name: MDSS AU Pty Ltd - Exabone Paste - Graft, bone, synthetic
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Intended Purpose

EXABONE PASTE is a synthetic osteoconductive bone paste intended to be used for filling and supporting the ingrowth of adjacent viable bone in bone defects that are not intrinsic to the stability of the bone structure. These defects may be located in the extremities, pelvis or dental, periodontal or mandibular areas, fractures, resection of benign tumours or cysts, for filling autograft harvest sites, for alveolar ridge or wall inclusive extraction sockets, and for filling of periodontal bone defects. EXABONE PASTE will act as a temporary scaffold and will remain as a soft paste and is not intended to provide structural support during the healing process. The implant is biocompatible, radio-opaque and will resorb in a controlled way.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
232998
Start Date
January 21, 2015
Effective Date
January 21, 2015
Sponsor
Manufacturer
Country
Switzerland
Address
Route de Saint-Cergue14, Nyon, CH1260