Search Results

The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials.

The General Cutting Contra Handpiece features an allowable maximum motor speed at 40,000 min-1 . The handpieces are provided optic and non-optic and are designed with a contra-angle appearance. Models are available to be connected directly onto motors compliant to ISO 3964. Available handpieces include the S-Max M Contra Series, Ti-Max X Contra Series, Ti-Max Z Contra Series and the Ti-Max nano Series.

The provided text describes a dental handpiece and does not contain information about an AI/ML device. Therefore, I cannot extract acceptance criteria or study details relevant to an AI/ML device from this document.

The document discusses:

• Device Name: General Cutting Contra Handpiece (a dental instrument)
• Manufacturer: NAKANISHI INC.
• Intended Use: Cutting and grinding teeth, cavity preparations, etc., in general dentistry.
• Regulatory Classification: Class I
• Bench Testing: Conformance to technical standards, internal specifications, and FDA guidance documents related to dental handpieces (e.g., sterilization, biocompatibility, electrical safety).
• Substantial Equivalence: Claimed based on similarities to predicate dental handpieces in intended use, operation principles, design, and medical use.

Since this is not an AI/ML device, the requested information regarding AI/ML-specific acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML does not apply to this document.

Ask a specific question about this device

The Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

The Medidental high speed handpiece is an air-powered dental handpiece which helps the dental clinician perform various dental procedures such as removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

The Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

The Medidental high speed handpiece is an air-powered dental handpiece which helps the dental clinician perform various dental procedures such as removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

This is a 510(k) premarket notification for a dental handpiece, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, expert involvement, MRMC study, standalone performance, ground truth, and training set is not applicable.

The provided document describes the substantial equivalence determination for:

• Trade Name: Elite Low Speed Air Motor with Elite "E" Contra-angle, Medidental High Speed Handpiece
• Common Name: Air-powered Low Speed Handpiece, E Type contra-angle, Air-powered High Speed Handpiece
• Classification Name: Handpiece, Air-Powered Dental
• Product Code: EFB (later listed as EFA in the FDA letter, which could be a typo or an update)

The device is intended to power various attachments for dental procedures such as removing carious material, excess filling material, cavity and crown preparation, root canal preparations, restoration, and polishing teeth.

The device was found substantially equivalent to the predicate device:

• Predicate Device: High & Low Speed Handpiece, with E-Type contra-angle (K073652) manufactured by NAKAMURA MAGNIFIER CO., LTD.

The FDA's review for such devices typically focuses on comparing the new device's technological characteristics and performance to a legally marketed predicate device to ensure it is as safe and effective. This generally involves mechanical and performance testing relevant to its function as a dental handpiece, such as speed, torque, vibration, noise, and compatibility with attachments, but not AI/ML-specific metrics.

Ask a specific question about this device