(184 days)
VOCO Paste is intended to be used after professional tooth whitening, professional tooth cleaning and for prevention and control of hypersensitivities.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for VOCO Paste. The document is an FDA 510(k) clearance letter, which primarily addresses the substantial equivalence of the device to a legally marketed predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(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.