Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Waterlase Express indications for use are as follows: General Hard Tissue Indications (for use on adult and pediatric patients) • Class I, II, III, IV and V cavity preparation • Caries removal • Hard tissue surface roughening or etching • Enameloplasty, excavation of pits and fissures for placement of sealants Root Canal Hard Tissue Indications • Tooth preparation to obtain access to root canal • Root canal preparation including enlargement • Root canal debridement and cleaning Root Canal Disinfection • Laser root canal disinfection after endodontic treatment Endodontic Surgery (Root Amputation) Indications • Flap preparation – incision of soft tissue to prepare a flap and expose the bone • Cutting bone to prepare a window access to the apex (apices) of the root(s) • Apicoectomy – amputation of the root end • Root end preparation for retrofill amalgam or composite • Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex Bone Surgical Indications • Cutting, shaving, contouring and resection of oral osseous tissues (bone) • Osteotomy Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patients) Incision, excision, vaporization, ablation and coagulation of oral soft tissues including: • Excisional and incisional biopsies • Exposure of unerupted teeth • Fibroma removal • Flap preparation – incision of soft tissue to prepare a flap and expose the bone • Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) • Frenectomy and frenotomy • Gingival troughing for crown impressions • Gingivectomy • Gingivoplasty • Gingival incision and excision • Hemostasis • Implant recovery • Incision and drainage of abscesses • Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery • Leukoplakia • Operculectomy • Oral papillectomies • Pulpotomy • Pulp extirpation • Pulpotomy as an adjunct to root canal therapy • Root canal debridement and cleaning • Reduction of gingival hypertrophy • Soft tissue crown lengthening • Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa • Vestibuloplasty • Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex Laser Periodontal Procedures • Full thickness flap • Partial thickness flap • Split thickness flap • 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 junctional epithelium • Removal of granulation tissue from bony defects • Sulcular debridement (removal of diseased, infected, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding in
The Waterlase Express indications for use are as follows: General Hard Tissue Indications (for use on adult and pediatric patients) • Class I, II, III, IV and V cavity preparation • Caries removal • Hard tissue surface roughening or etching • Enameloplasty, excavation of pits and fissures for placement of sealants Root Canal Hard Tissue Indications • Tooth preparation to obtain access to root canal • Root canal preparation including enlargement • Root canal debridement and cleaning Root Canal Disinfection • Laser root canal disinfection after endodontic treatment Endodontic Surgery (Root Amputation) Indications • Flap preparation – incision of soft tissue to prepare a flap and expose the bone • Cutting bone to prepare a window access to the apex (apices) of the root(s) • Apicoectomy – amputation of the root end • Root end preparation for retrofill amalgam or composite • Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex Bone Surgical Indications • Cutting, shaving, contouring and resection of oral osseous tissues (bone) • Osteotomy Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient) Incision, excision, vaporization, ablation and coagulation of oral soft tissues including: • Excisional and incisional biopsies • Exposure of unerupted teeth • Fibroma removal • Flap preparation – incision of soft tissue to prepare a flap and expose the bone • Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) • Frenectomy and frenotomy • Gingival troughing for crown impressions • Gingivectomy • Gingivoplasty • Gingival incision and excision • Hemostasis • Implant recovery • Incision and drainage of abscesses • Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery • Leukoplakia • Operculectomy • Oral papillectomies • Pulpotomy • Pulp extirpation • Pulpotomy as an adjunct to root canal therapy • Root canal debridement and cleaning • Reduction of gingival hypertrophy • Soft tissue crown lengthening • Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa • Vestibuloplasty • Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualif
Waterlase Express is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr:YSGG) solid-state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2780 nm. The laser system consists of a top-table console which houses the laser head, power supply, cooling system, micro-processor and a removable tablet PC as a control panel. A flexible fiber cable, connected to the laser console, delivers laser energy to the treatment site through a laser tip attached to a Handpiece. A visible light emitted from the Handpiece head illuminates the area. The laser is activated by means of a wireless footswitch. Various laser tips are available for different clinical applications. Waterlase Express utilizes advanced laser and water atomization technologies to cut, shave, contour, roughen, etch and resect oral hard tissues, and direct laser energy, with or without water for cooling and hydration, to perform oral soft tissue removal, incision, excision, ablation and coagulation as well as specific endodontic and periodontal applications.
Summary parsed at:2026-06-01 06:06:30 UTC
