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K Number
K042056
Device Name
AZ ULTRASONIC SYSTEM
Manufacturer
J. MORITA USA, INC.
Date Cleared
2004-09-30

(62 days)

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

The AZ Ultrasonic System is an Ultra Scaler intended for use with an appropriate tip for scaling, crown removal, amalgam condensation, excavating, periodontic or endodontic use.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called "AZ Ultrasonic System." It primarily confirms that the device is substantially equivalent to a legally marketed predicate device. The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed study proving performance against specific acceptance criteria.

§ 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.