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K Number
K052700
Device Name
PANA-SPRAY
Manufacturer
NSK AMERICA CORP.
Date Cleared
2005-12-20

(83 days)

Product Code
EFB
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K052700
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This new device is a lubricant and is intended for use to lubricate the dental and medical surgical handpieces.

Device Description

This new device is a lubricant and is intended for use to lubricate the dental and medical surgical handpieces.

AI/ML Overview

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a dental handpiece lubricant called "Pana-Spray", indicating it is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, intended use, and general controls, but not specific performance criteria or a study proving those criteria are met.

§ 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.