Solea

The Solea system is indicated for the following: - Ablation of hard tissue for caries removal and cavity preparation. - Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity. General Indications: 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. For use on adult and pediatric patients. 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 instrumentation. Bone Surgical Indications: Cutting, shaving, contouring and resection of oral osseous tissues (bone), Osteotomy. 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 ablation coagulation. Soft Tissue Indications including Pulpal Tissues: 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, Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage, Frenectomy and frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingival incision and excision, Hemostasis.

The Solea system is indicated for the following: - Ablation of hard tissue for caries removal and cavity preparation. - Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity. General Indications: 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.

The Solea system is a dental laser device previously cleared by the FDA for soft tissue dental indications (K123494) and hard tissue indications (K130420). The only changes from the previously cleared device are the addition of the osseous tissue indications. There have been no software changes or graphic changes to the Solea system. The osseous tissue settings are the same as the previously cleared device (K130420).