Pure Global

Biofilling Kit - Dental material kit, root obturation, synthetic

Access comprehensive regulatory information for Biofilling Kit - Dental material kit, root obturation, synthetic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Tomident Pty Ltd, manufactured by BioMTA in South Korea. The device registration started on July 26, 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.

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TGA ARTG Official Data
Class I
Class I
Biofilling Kit - Dental material kit, root obturation, synthetic
Australia TGA ARTG Registered Device
Good Name: Tomident Pty Ltd - Biofilling Kit - Dental material kit, root obturation, synthetic
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Intended Purpose

An assembly of endodontic instruments intended to be used for filling the root canal as part of endodontic obturation procedures. This device does not include the synthetic filling materials.

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
July 26, 2022
Effective Date
July 26, 2022
Sponsor
Manufacturer
Name
BioMTA
Country
South Korea
Address
(Yongsan-dong) 41 Techno8-ro, Yuseong-gu, Daejeon