510(k) · Cleared
ClearedSimplex Airbrator (Sab-7)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irt Management Corp. · KOJ Airbrush
Cleared on May 4, 2000 after an 804-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 4, 2000
- Review
- 804 days
- Class
- Class II
- Product code
- KOJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KOJ device
- #1 K251425 turbodent touchscore 11.1 · 7 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KOJ devicesKOJ Airbrush: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOJ
Too few KOJ 510(k)s in any year since 2007 to give a median.
Recalls per year · KOJ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOJ
2in 2025
MAUDE reports naming product code KOJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (159 words)
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
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980672: Simplex Airbrator (Sab-7).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980672
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026