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510(k) Data Aggregation
K Number
K042114Device Name
MDL SERIES DIODE LASERS, MODEL MDL-10/15
Manufacturer
Date Cleared
2006-02-03
(547 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
VISION LASERTECHNIK, GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MDL Laser System is intended for use as a dental laser, with specific application in oral soft tissue for incision, excision, vaporization, ablation and coagulation. Indications for use include the following:
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 Loukoplakia 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
Device Description
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