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K Number
K113430
Device Name
PROULTRA PIEZO ULTRASONIC
Manufacturer
SATELEC-ACTEON GROUP
Date Cleared
2012-02-23

(94 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 ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator intended for use with The Frookia , lead on for, scaling, periodontics, prosthesis and endodontic Dental Applications.

Device Description

ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental ultrasonic generator for use in scaling, periodontics, prosthesis and endodontics. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. Therefore, I cannot fulfill your request based on the provided text.

§ 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.