Search Results

Light activation for bleaching materials for teeth whitening. Laser-assisted bleaching/whitening for teeth.

Not Found

The provided 510(k) summary for the DioDent Dental Laser System (K022351) explicitly states:

Clinical Performance Data: None.

Therefore, there is no information in the provided document about acceptance criteria or a study that proves the device meets any such criteria. This submission relies on substantial equivalence to predicate devices based on principles of operation, function, and intended use, rather than on clinical performance data.

Ask a specific question about this device

The DioDent Dental Laser System is intended for incision, excision, ablation, vaporization and/or coagulation of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva).
For the incision, excision, ablation, vaporization and hemostasis of oral soft tissue. Examples: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunt to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Sucular 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) Treatment of aphthous ulcers Vestibuloplasty Biopsy incision and excision Lesion (tumor) removal

Not Found

The provided document is a 510(k) summary for the DioDent Dental Laser System. It states that no nonclinical or clinical performance data was provided or used to establish the substantial equivalence of the device.

Therefore, I cannot provide information on acceptance criteria and the study that proves the device meets those criteria, as no such study was presented in this submission. The device was deemed substantially equivalent to predicate devices based on its operating parameters, physical characteristics, and intended uses without requiring new performance data.

Ask a specific question about this device