# K980672: Simplex Airbrator (Sab-7)

- Pathway: 510(k) (Traditional)
- Applicant: Irt Management Corp.
- Decided: May 4, 2000 after 804 days
- Product code: KOJ (Airbrush)
- Device class: 2
- Regulation: 21 CFR 872.6080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
General Usage: Cleaning of Tooth Surfaces Stain Removal from Tooth Surfaces Removal of Surface Deposits from Teeth Cleaning of Dental Pits and Fissures Microetching of enamel and dentin surfaces in preparation for adhesive bonding procedures Preparation (mechanical cleansing and etching) of metallic, ceramic, composite and acrylic 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) Preparation 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

Source page: https://510kreport.com/device/K980672
Methodology: https://510kreport.com/methodology