Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
Epic 980 is indicated for: 1. Dental soft tissue indications - Incision, excision, vaporization, ablation, and coagulation of oral soft tissue including marginal and inter-dental gingiva 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, and tissue retraction for impression.
Epic 980 is indicated for: 1. Dental soft tissue indications - Incision, excision, vaporization, ablation, and coagulation of oral soft tissue including marginal and inter-dental gingiva 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, incisions and draining of abscesses, 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 impressions. 2. Laser Periodontal Procedures - Laser soft tissue curettage, laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal packet, sulcular debridement. 3. Whitening - Laser activation for bleaching materials for teeth whitening, laser assisted whitening/bleaching of teeth. 4. Pain Relief - 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 muscle back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
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 Epic 980 uses an Indium Gallium Arsenide (InGaAs) 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. A visible light is emitted at the same time to visually identify the treatment location. 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 05:55:52 UTC
