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K Number
K081811
Device Name
CARE3 PLUS
Manufacturer
NAKANISHI, INC.
Date Cleared
2009-01-21

(209 days)

Product Code
EFB
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Care3 Plus is intended for internal cleaning, i e , purging of old lubricant, for the maintenance of rotating dental and surgical instruments

NOTE Care3 Plus should be used with only pre-cleaned dental handpieces and before they are sterilized

Device Description

Care3 Plus

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental handpiece and accessories called "Care3 Plus." It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

Therefore, I cannot provide the requested information from this document.

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.