Pure Global

File, dental, hand-held, margin finishing

Access comprehensive regulatory information for File, dental, hand-held, margin finishing in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Erskine Products Pty Ltd, manufactured by LM-Instruments Oy in Finland. The device registration started on March 13, 2024.

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
File, dental, hand-held, margin finishing
Australia TGA ARTG Registered Device
Good Name: Erskine Products Pty Ltd - File, dental, hand-held, margin finishing
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Intended Purpose

A hand-held manual dental instrument that has various forms of fine ridged cutting surfaces at its working end(s) designed to smooth and shape a tooth, an approximate bone (e.g., alveolar) and/or a dental restoration (e.g., filling). This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 13, 2024
Effective Date
March 13, 2024
Manufacturer
Country
Finland
Address
Norrbyn rantatie 8, PARAINEN, FI-21600