Search Results
Found 2 results
510(k) Data Aggregation
K Number
K081652Device Name
CLAROS NANO DENTAL LASER SYSTEM
Manufacturer
ELEXXION AG
Date Cleared
2008-08-28
(77 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ELEXXION AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental 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, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectorny, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscesses, Leukoplakia, Operculectomy, Oral papillectornies, 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, and Vestibuloplasty. Laser Periodontal Procedures: Laser soft tissue curettage, Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility). Tooth Whitening: Laser assisted whitening/bleaching of teeth, Light activation for bleaching materials for teeth whitening.
Device Description
The Claros nano Dental Laser System is a variant of the Claros Dental Laser System. It is a portable laser that uses a gallium aluminum arsenide 810 nm diode laser module to provide optical energy via a contact fiber optic delivery system. Claros nano is used for multiple soft tissue, periodontal, and teeth whitening applications. The Claros nano Dental Laser System is comprised of the following main components: a light/ laser system console (including software, a display panel and controls); delivery devices; one or more handpieces; and protective eye wear.
Ask a Question
K Number
K063152Device Name
CLAROS DENTAL LASER SYSTEM
Manufacturer
ELEXXION AG
Date Cleared
2007-03-07
(142 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ELEXXION AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental 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, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectorny, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscesses, Leukoplakia, Operculectormy, 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, and Vestibuloplasty. *For use on adult and pediatric patients. Laser Periodontal Procedures: Laser soft tissue curettage, Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility). Tooth Whitening: Laser assisted whitening/bleaching of teeth, Light activation for bleaching materials for teeth whitening.
Device Description
The Claros Dental Laser System is a portable laser that uses a gallium aluminum arsenide 810 nm diode laser module to provide optical energy via a contact fiber optic delivery system. Claros is used for multiple soft tissue. periodontal, and teeth whitening applications. The Claros Dental Laser System is comprised of the following main components: a light/ laser system console (including software, a display panel and controls); delivery devices: one or more handpieces; key cards for security; and protective eve wear.
Ask a Question
Page 1 of 1