Australia TGA ARTG recordDental diode laser system
Australia TGA ARTG Registered Device · Ultradent Australia Pty Ltd · Azena Medical LLC · Class IIb · Started December 14, 2023
Good Name: Ultradent Australia Pty Ltd - Dental diode laser system
- Risk Class
- Class IIb
- Product Type
- Medical device system
- ARTG Category
- General
- Start Date
- December 14, 2023
- Effective Date
- December 14, 2023
- Country
- United States of America
- Address
- 3021 Citrus Circle ,Ste 180, Walnut Creek, California, 94598
The Gemini EVO 810+980 soft tissue laser is intended for the incision, excision, vaporization, ablation, and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies/ Exposure of unerupted teeth/ Fibroma removal/ Frenectomy/ Frenotomy/ Gingival troughing for crown impressions/ Gingivectomy/ Gingivoplasty/ Gingival incision and excision/ Hemostasis and coagulation/ Implant recovery/ Incision and drainage of abscess/ Leukoplakia/ Operculectomy/ Oral papillectomies/ Pulpotomy/ Pulpotomy as an adjunct to root canal therapy/ Reduction of gingival hypertrophy/ Soft tissue crown lengthening/ Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa/ Treatment of aphthous ulcers/ Vestibuloplasty/ Tissue retraction for impression/ Lesion (tumor) removal. Laser Periodontal Procedures Laser soft tissue curettage/ Laser removal of diseased, Infected, Inflamed and necrosed soft tissue within the periodontal pocket/ Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium/ Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)/ Reduction of bacterial level (decontamination) and inflammation Pain therapy Topical heating for the purpose of elevating tissue temperature for the temporary increase in local blood circulation.
Access comprehensive regulatory information for Dental diode laser system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Ultradent Australia Pty Ltd, manufactured by Azena Medical LLC in United States of America. The device registration started on December 14, 2023.
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.