LogoFDA 510(k) Search
K Number
K031421
Device Name
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
Manufacturer
NAKANISHI, INC.
Date Cleared
2004-03-26

(326 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

These devices are ultrasonic scalers, intended for use with an appropriate tip for scaling, crown removal, amalgam condensation, excavating, periodontal, and endodontic use.

Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter dated March 26, 2004, for the Nakanishi, Inc. Varios ultrasonic scalers (Models 350, 350 Lux, 150, 150 Lux, and 550) does not contain information about acceptance criteria, device performance, or any studies as requested.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA's decision is based on a comparison to existing devices already on the market, rather than requiring the submission of new clinical or performance study data with specific acceptance criteria.

Therefore, I cannot provide the requested information based on the provided 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.