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K Number
K093000

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Device Name
EMS PIEZON MASTER 700
Manufacturer
EMS ELECTRO MEDICAL SYSTEMS SA
Date Cleared
2010-07-30

(305 days)

Product Code
ELC
Regulation Number
872.4850
Type
Traditional
Panel
Dental
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K093723,K110173,K130025,K132445,K133752,K233844
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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.