Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
Indicated for incision, excision, vaporization, ablation and coagulation of oral soft-tissues (intraoral and extraoral) 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 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 • Vestibuloplasty • Tissue retraction for impression • Laser soft-tissue curettage
Dental Soft Tissue Indications 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 • Vestibuloplasty • Tissue retraction for impression • Laser soft-tissue curettage • Laser removal of diseased, infected, inflamed and necrosed soft-tissue within the periodontal pocket • 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 • Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium • Lesion (tumor) removal • Removal of hyperplastic tissues • Laser assisted flap surgery • Removal of granulation tissue Whitening • Light activation for bleaching materials for teeth whitening • Laser-assisted whitening/bleaching of teeth Pain Therapy • Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary
The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain. The device uses a solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site. The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications.
Summary parsed at:2026-06-01 05:47:26 UTC
