(167 days)
The SonX 35 Ultrasonic Bleaching System is used to accelerate the action of a tooth bleaching medium by introducing energy into said medium in the form of ultrasonic vibrational impulses at a frequency cycled between 25000 and 30000 hertz, improving the appearance of teeth.
The SonX 35 Ultrasonic Bleaching System is a device used in the application of dentifrice compositions for the purpose of whitening teeth. This device aids in the performance of these compositions by providing energy in the form of ultrasonic wave energy. Transducers that are fully encased in the portion of the tray external to the patient generate the ultrasonic energy at a frequency that is sinusoidally cycled between 25,000 and 30,000 hertz. Electrical pulses of a voltage not exceeding 7VDC and 300mA current are supplied to the transducers by means of a separate power source unit, which delivers the energy by means of insulated conductors attached to an appendage of the tray device. All electrical connections are external of the patient, and the transducer electrical supply is electrically isolated from the main power supply.
The provided text is a 510(k) summary for the SonX 35 Ultrasonic Bleaching System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The document states: "Performance Standards: The SonX 35 Ultrasonic Bleaching System complies with the performance requirements of 21 CFR 1050, and the electrical safety requirements of IEC 60601-1 and IEC 60601-2-5." It also mentions "Clinical Performance Data See Part 7: Performance Data" but Part 7 is not included in the provided text.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and the study that proves the device meets those criteria from the given text.
The available information only states that the device is compliant with certain general performance and electrical safety standards, and refers to a "Part 7: Performance Data" which is not provided. No clinical study details (sample size, ground truth, expert qualifications, etc.) are present in the extract.
§ 872.6475 Heat source for bleaching teeth.
(a)
Identification. A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.