K Number
K051547
Date Cleared
2005-07-14

(31 days)

Product Code
Regulation Number
872.4850
Panel
DE
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PowerMAX Ultrasonic Scaler is intended for use during dental cleanings and periodontal therapy to remove calculus deposits form teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a dental ultrasonic scaler, not an AI/ML device, therefore the requested information regarding acceptance criteria, study data, sample sizes, and expert adjudication for AI/ML performance is not applicable. The document confirms that the device, PowerMAX Ultrasonic Scaler, is substantially equivalent to legally marketed predicate devices for dental cleanings and periodontal therapy.

§ 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.