VELOPEX AQUACUT FLUID ABRASION UNIT

• K Number: K024105
• Device Name: VELOPEX AQUACUT FLUID ABRASION UNIT
• Manufacturer: VELOPEX INTERNATIONAL, INC.
• Date Cleared: 2003-10-09 ( 300 days)
• Product Code: KOJ
• Regulation Number: 872.6080
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

FOR PIT AND FISSURE SEALANTS. PREPARATION REMOVAL AND RESICRATION OF COMPOSITS . CAVITY PREPARATION. CLEANING, POLISHING AND STAIN REMOVAL,

Device Description

Not Found

AI/ML Overview

The provided FDA letter for K024105, "Velopex Aquacut Fluid Abrasion Unit," does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The letter is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study results against specific acceptance criteria.

Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for either the test or training sets, as this information is not present in the provided document.

The document only states the "Indications For Use" which are:

• FOR PIT AND FISSURE SEALANTS. PREPARATION
• REMOVAL AND RESTORATION OF COMPOSITES.
• CAVITY PREPARATION.
• CLEANING, POLISHING AND STAIN REMOVAL.

Regulation Number and Section

§ 872.6080 Airbrush.

(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”