SIMPLEX AIRBRATOR (SAB-7)

• K Number: K980672
• Device Name: SIMPLEX AIRBRATOR (SAB-7)
• Manufacturer: IRT MANAGEMENT CORP.
• Date Cleared: 2000-05-04 ( 804 days)
• Product Code: KOJ
• Regulation Number: 872.6080
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

General Usage: Cleaning of Tooth Surfaces Stain Removal from Tooth Surfaces Removal of Surface Deposits from Toeth Cleaning of Dental Pits and Fissures Microciching of enamel and dentin surfaces in preparation for adhesive bonding procedures Microciding of enamer and deching and etching) of metallic, ceramic, composite and actylic surfaces for dental procedures including bonding, cementation, repair and restoration Delivers a controlled stream of particles for the removal of tooth structure Specific Dental Usage: Preparation of tooth surfaces for sealants Preparation of tooth surfaces for orthodontic bracket bonding Preparation of tooth surfaces for bonding bridges Preparation of internal root surfaces for post procedures (after root canal therapy) I reparation of tooth surfaces for adhesive bonding procedures, ceramic inlays, crowns and bridges Preparation of root surfaces for periodontal procedures Repair of composite, acrylic and ceramic restorations Occlusal adjustments and equilibration Repair of prosthetic appliances Bonded splint procedures Removal of cement from temporary and permanent procedures Class I-V cavity preparation NOT FOR USE ON AMALGAM

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the BioStar Airbrator (trade name SIMPLEX™ AIRBRATOR™). It primarily lists the device's intended uses and confirms its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information from this document.

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.”