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This device indicated for use the Incision, Alblation, Vaporization and Hemostasis of oral soft tissue such as, Excisional and Incisional biopsies, Exposure of Un-erupted teeth, Fibroma Removal, Frenectomy and Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingvioplasty, Gingival Incision and Excision, Implant recovery, Incision and drainage of abscess, Leukoplakia, Operculectomy, Oral Papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Sulcular debridement, Treatment of aphthous ulcers Vestibuloplasty, Biopsy incision and excision, lesion (tumor) removal, Light activation for bleaching material, for laser assisted bleaching/ whitening for teeth.

Dental 5 multi Diode laser system are producing 81

The provided document is a 510(k) premarket notification letter from the FDA for a dental laser device. It does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

The document explicitly states:

• "Clinical and Non-Clinical performance test data was not provided in this submission." (See page 4, Section 6. Performance test)

Therefore, I cannot extract the requested information from this document. The device's substantial equivalence to a predicate device was based on similarities in design, construction, energy rate, pulse duration, cooling system, and intended use, along with adherence to mandatory and voluntary standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 62304) and sterilization/disinfection validations.

To answer your request, clinical and non-clinical performance test data would be required, which is absent from this submission.

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