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K Number
K072213
Device Name
PERIMETRICS PERIOMETER
Manufacturer
PERIMETRICS, INC.
Date Cleared
2008-08-29

(386 days)

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

The Periometer is a unit that precisely measures the damping characteristics of the periodonium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

Device Description

Not Found

AI/ML Overview

I'm sorry, but without access to the full 510(k) submission document for K072213, I cannot provide details on the acceptance criteria, device performance, or study specifics for the Periometer device. The provided text is only the FDA's decision letter and the Indications for Use statement, which does not contain the detailed technical data and study information required to answer your questions.

§ 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.