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Dental wedge, single-use - ARTG 356857

Access comprehensive regulatory information for Dental wedge, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 356857 and sponsored by Henry Schein Halas, manufactured by Ortho Arch Company Inc in United States of America. The device registration started on March 16, 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 IIa
ARTG 356857
Class IIa
Dental wedge, single-use
ARTG ID: 356857
Good Name: Henry Schein Halas - Dental wedge, single-use
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Intended Purpose

To be used in orthodontic appliances to lock into place adjacent to the tie wing of an orthodontic bracket and provide a fulcrum between the wire and bracket for rotation of a tooth during treatment.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
356857
Start Date
March 16, 2021
Effective Date
March 16, 2021
Manufacturer
Country
United States of America
Address
1107 Tower Road, Schaumburg, Illinois, 60173