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K Number
K014238
Device Name
DELSONIC 2000
Manufacturer
DELDENT LTD.
Date Cleared
2002-01-24

(29 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

The Delsonic 2000 Ultrasonic Scaler is intended to be used for fast and reliable removal of light to heavy calculus and plaque. This 29KHz Ultrasonic system
removal of light to h removal or light to tight to time for each scaling insert.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Delsonic 2000 Ultrasonic Scaler. It confirms that the device is substantially equivalent to a legally marketed predicate device.

It does NOT contain information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The content is primarily administrative, confirming FDA clearance and outlining general regulatory requirements.

§ 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.