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K Number
K983727
Device Name
BIOSONIC ULTRASONIC SCALER SYSTEM
Manufacturer
COLTENE/WHALEDENT INC.
Date Cleared
1999-01-20

(90 days)

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

Ultrasonic applications for: All subgingival and supra gingival scaling, Periodontal therapy, and routine prophylaxis procedures

Device Description

BioSonic Ultrasonic Scaler System

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for a device called "BioSonic Ultrasonic Scaler System". This document does not describe acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or any of the other specific details requested in the prompt about a clinical study for a medical device.

The letter is an approval notification for marketing the device based on its substantial equivalence to a legally marketed predicate device, not a report on the results of a contemporary performance study.

Therefore, I cannot fulfill the request using only the provided text. The requested information is not present in this document.

§ 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.