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BVital Form RCM - Collagen dental regeneration membrane - ARTG 376528

Access comprehensive regulatory information for BVital Form RCM - Collagen dental regeneration membrane in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 376528 and sponsored by More Group Pty Ltd, manufactured by Collagen Matrix Inc in United States of America. The device registration started on October 18, 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 III
ARTG 376528
Class III
BVital Form RCM - Collagen dental regeneration membrane
ARTG ID: 376528
Good Name: More Group Pty Ltd - BVital Form RCM - Collagen dental regeneration membrane
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Intended Purpose

BVital FORM RCM is a bioresorbable, implantable collagen material that is intended for use in oral surgical procedures as a resorbable membrane material for use in - simultaneous use of guided bone regeneration (GBR)-membrane and implants; - augmentation around implants placed in immediate extraction sockets; - augmentation around implants placed in delayed extraction sockets; - localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment; - filling of bone defects after root resection, cystectomy or removal of retained teeth; - guided bone regeneration in dehiscence defects; and - guided tissue regeneration procedures in periodontal defects.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
376528
Start Date
October 18, 2021
Effective Date
October 18, 2021
Manufacturer
Country
United States of America
Address
15 Thornton Road, Oakland, NJ, 07436