Device Dossier

Dental diode laser system

Device Dossier for Dental diode laser system (Dental diode laser system, Class IIb, sponsor Ultradent). ARTG record, intended purpose, GMDN category —…

Intended purpose

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.

TGA Public Summary