(87 days)
BONART's ART-P3II & ART-P4 Piezo Ultrasonic Scaler are intended for use by medical professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Tip". Tips come in various shapes (BS1, BS2, BS3 etc.) and are designed to generate a vibrating frequency of 29Khz.
BONART ART-P3II PIEZO ULTRASONIC SCALER & ACCESSORIES (TIPS) BONART ART-P4 PIEZO ULTRASONIC SCALER & ACCESSORIES (TIPS)
The provided text is an FDA 510(k) clearance letter for an ultrasonic scaler. It does NOT contain any information about acceptance criteria or a study proving device performance against such criteria.
The document primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the device name, regulation number, regulatory class, and product code. It also includes an "Indications for Use" statement.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study to prove the device meets them, as this data is entirely absent from the provided text.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.