LogoFDA 510(k) Search
K Number
K964320

Validate with FDA (Live)

Device Name
TONY RISO 25/30 MULTIFUNCTION SCALER
Manufacturer
TONY RISO CO., INC.
Date Cleared
1997-01-23

(86 days)

Product Code
ELC
Regulation Number
872.4850
Type
Traditional
Panel
Dental
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K983029,K994203
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 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.