Get To Know The Device; Intended Use; Clinical Summary Data - Silk’n ToothWave H7001 Manual Del Usuario

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Additional warnings:
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Do not bite the brush head.
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The safety and effectiveness of the device for uses other
than those indicated are not known.

3. Get to know the device

3.1 Intended use

The device is intended for daily oral hygiene, including: plaque
removal, calculus reduction, and the prevention and reduction
of gingivitis. The device is also intended for the removal of teeth
discoloration, stains, plaque and tartar (calculus).
The device is for personal home-use only, and is not intended for
use on multiple patients in a dental practice or institution. Do not
use for any purpose other than as described in this user manual.

3.2 Clinical summary data

A single-blind randomized double arm prospective study was
performed with 85 subjects. The purpose of the study was to
test the safety and efficacy of the device.
Subjects were randomized into one of two study groups,
receiving either the RF powered toothbrush (n=44), or a control
powered toothbrush (n=41). The subjects performed twice daily
brushing for a test period of 6 weeks. Plaque (RMNPI), calculus
(V-MI), gingival inflammation (MGI) and bleeding (GBI) were
assessed at baseline, after 4 and 6 weeks. Results were compared
within each group and between the groups.
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