(189 days)
The VIP 60 is an instrument of calculus and plaque removal which the dentist uses for dental treatment. This VIP 60 is used with scaling tips and a coolant water spray for debriding heavy calculus and plaque deposits from tooth and root surfaces.
The VIP 60 is an air scaler used with scaling tips and a coolant water spray. It is described as causing much less pain, less oppressive pain and irritation, and much less bleeding compared to ultrasonic scaling. It also provides post operative refreshness from pocket irrigation. For operators, it allows direct connection to a handpiece hose, minimum water spraying for clear visibility, and a delicate tip for reaching subgingival pockets, interdental areas, and molar furcations. The delicate tip also allows the operator to feel calculus adherence and avoid touching hypersensitive areas.
The provided text is a 510(k) summary for the MICRON CORPORATION VIP 60 air scaler. It details the device's intended use, description, and claims of substantial equivalence to a predicate device (KAVO AMERICA'S SONICFLEX). This document focuses on regulatory approval based on equivalence rather than explicit performance criteria defined by a study against specific acceptance metrics.
Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, a study proving the device meets those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The 510(k) process for this device relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing features, intended use, technological characteristics, and safety and effectiveness information, rather than conducting new clinical trials to establish de novo performance against acceptance criteria.
The information relevant to the provided text is as follows:
- Device Name: VIP 60 Model 115-000-1 and Model 115-000-2 (Sonic Scaler)
- Intended Use: "The VIP 60 is an instrument of calculus and plaque removal which the dentist uses for dental treatment. This VIP 60 is used with scaling tips and a coolant water spray for debriding to heavy calculus and plaque deposits from tooth and root surfaces."
- Predicate Device: KAVO AMERICA'S SONICFLEX
- Technological Characteristics and Substantial Equivalence: "The general components, design, characteristics, and mode of operation of the VIP60 and accessories are substantially Equivalent to Kavo America's SONICFLEX."
Without a separate clinical performance study described in the document, it's impossible to fill in the requested table and details.
§ 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.