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K Number
K062418
Device Name
K-SPRAY, MODEL 085-2715
Manufacturer
SCICAN
Date Cleared
2006-10-19

(62 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

K-SPRAY is intended for the maintenance and lubrication of dental handpieces.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental handpiece maintenance and lubrication device called "K-SPRAY." This document does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details about an AI/algorithm-based medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on 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.