High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)

• K Number: K241074
• Device Name: High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
• Manufacturer: Foshan SOCO Precision Instrument Co.,Ltd.
• Date Cleared: 2024-11-12 ( 207 days)
• Product Code: EFB , EGS
• Regulation Number: 872.4200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K220179

Intended Use

High-speed Air Turbine Handpieces: It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors: It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Device Description

The proposed device is used to hold rotary instruments such as burs and drills to drive movements to achieve dental operations such as cutting, and drilling. The working principle of the proposed device is that the current and compressed air arrive at the nose through each control valve of the circuit system and air circuit system to drive the motor, turbine (or blade) rotation (shaft core rotation), thus driving the needle rotation to achieve the purpose of drilling and tooth cutting, and the other water and air meet the head to achieve the cooling purpose through each control valve.

AI/ML Overview

The provided text is a 510(k) Summary for dental handpieces, which focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed device performance metrics.

Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported device performance directly from this document. The document primarily highlights that the proposed device met design specifications and performed as well as the legally marketed predicate device based on non-clinical tests compliant with various ISO and IEC standards. It explicitly states, "No clinical study is included in this submission."

Given this, I am unable to provide a response that directly answers your request for acceptance criteria and device performance from a clinical study, sample sizes for test sets, expert involvement, adjudication methods, MRMC study details, standalone performance, or training set specifics, as these are details typically found in clinical performance studies, not in this type of 510(k) submission.

The document focuses on non-clinical testing for safety and effectiveness, and comparability to a predicate device.

Regulation Number and Section

§ 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.