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Dental implant stability measurement control unit

Access comprehensive regulatory information for Dental implant stability measurement control unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by DIO Australia Pty Ltd, manufactured by Osstell AB in Sweden. The device registration started on December 18, 2019.

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 IIa
Class IIa
Dental implant stability measurement control unit
Australia TGA ARTG Registered Device
Good Name: DIO Australia Pty Ltd - Dental implant stability measurement control unit
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Intended Purpose

DIO IDx is intended for use as a Dental Implant Stability Analyzer. The device is a handheld instrument that involves the use of the non-invasive technique, Resonance Frequency Analysis. The system involves the use of a SmartPeg attached to the dental implant or abutment by means of an integrated screw which is excited by a magnetic pulse from the measurement probe in the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed on the instrument as the Implant Stability Quotient (ISQ). It is a measurement of the stability of the implant, and is derived from the resonance frequency value obtained from the SmartPeg. The higher the number, the greater the stability. The system includes the DIO IDX, probe, smart peg mount, charger and test peg. The Smart Peg is sold separately as a single use device and not included with the system.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
December 18, 2019
Effective Date
December 18, 2019
Manufacturer
Country
Sweden
Address
Stampgatan 14, Goteborg, S-411 01