Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
Waterlase Laser System Family is intended for use in oral hard and soft tissue dental applications. The Indications for Use are as follows: Waterlase laser removal of porcelain and ceramic crowns and veneers 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 NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. 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 NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Laser Periodontal Procedures • Full thickness flap • Partial thickness flap • Split thickness flap • Laser soft tissue curettage • Laser removal of diseased,
Waterlase laser removal of porcelain and ceramic crowns and veneers. 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.
Waterlase Laser System Family utilizes an Er, Cr:YSGG (2780nm) solid-state laser and water atomization technology to safely and effectively cut, shave, contour, roughen, etch and resect oral hard-tissue and direct laser energy to perform oral soft tissue removal, incision, excision, ablation and coagulation. It is also used for specific endodontic and periodontal applications. A single laser console houses the laser head, power supply, cooling system, micro-processor. The laser is controlled through a display which serves as the User Interface. A flexible fiber optic cable, connected to the laser, 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. A fine water spray is also emitted from the handpiece head to cool and hydrate the issue. A variety of laser tips are available for different clinical applications. The laser is activated by a footswitch.
Summary parsed at:2026-06-01 05:55:09 UTC
