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K Number
K111616
Device Name
E-CUBE
Manufacturer
SAESHIN PRECISION CO., LTD.
Date Cleared
2011-08-19

(70 days)

Product Code
EKX
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K092614,K092412
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The E-CUBE is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills(Gates-Glidden).

Device Description

The E-CUBE is an AC-powered device that includes a hand-held motor and controller for regulation of speed and direction of rotation or a contra-angle attachment for dental implant surgery.

AI/ML Overview

The provided document describes a 510(k) summary for the Saeshin E-CUBE, a dental handpiece. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, design, and adherence to safety standards.

However, the document does not contain any information regarding specific acceptance criteria for device performance, nor details of a study that proves the device meets such criteria in terms of clinical performance or accuracy.

Instead, the document highlights:

  • Substantial Equivalence: The E-CUBE is deemed substantially equivalent to predicate devices (X-Smart Easy, K092614, and STRONG Implant Handpiece, K092412) in terms of intended use, materials, design, and use concept.
  • Biocompatibility Testing: Biocompatibility of patient contact parts was demonstrated through cytotoxicity, sensitization, and irritation testing according to ISO 10993-1.
  • Safety Standards: The device conforms to IEC 60601-1 (Medical electric equipment, Part 1: General requirements for safety) and IEC 60601-1-2 (electromagnetic compatibility).

Therefore, I cannot provide the requested table or detailed study information as it is not present in the provided text. The document focuses on regulatory compliance and equivalence to established devices rather than reporting on a specific performance study with defined acceptance criteria and clinical outcomes.

§ 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.