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K Number
K123695
Device Name
TRAUS SIP10
Manufacturer
SAESHIN PRECISION CO., LTD.
Date Cleared
2012-12-18

(15 days)

Product Code
EKY
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K052741,K011061
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The TRAUS SIP10 is intended for use in dental surgery, implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.

Device Description

The TRAUS SIP10 is an AC-powered device that includes a hand-held motor, controller, contra angle handpiece and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental implant surgery.

AI/ML Overview

The provided text is a 510(k) summary for the Saeshin TRAUS SIP10 dental handpiece. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or adjudication methods for an AI-powered device. Therefore, I cannot generate the requested table and information based on this document.

The document discusses:

  • Company and Device Information: Saeshin Precision Co., Ltd., and the TRAUS SIP10 dental handpiece.
  • Predicate Device: ImplantMED SI-915/923, K052741, and Surgical Contra-Angle Handpiece WS-75E/KM, K011061.
  • Device Description and Indication for Use: The TRAUS SIP10 is an AC-powered dental handpiece for surgery, implantology, maxilla-facial surgery, and endodontics.
  • Bench Testing and Standards Conformance: Biocompatibility testing (ISO 10993-1) and conformance to electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2) are mentioned to demonstrate safety and effectiveness.
  • Substantial Equivalence: The document concludes that the TRAUS SIP10 is substantially equivalent to the predicate device based on similar intended use, material, design, and use concept.

There is no mention of AI, machine learning, or software-based performance evaluation studies that would typically involve acceptance criteria, test sets, ground truth, or expert review as described in your request.

§ 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.