510(k) · Cleared
ClearedAccu-Prep
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · KOJ Airbrush
Cleared on Jul 1, 1997 after a 141-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 1, 1997
- Review
- 141 days
- Class
- Class II
- Product code
- KOJ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Microetcher Named without a submission number |
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?
1. Maryland Bridges (resin bonded bridges): for preparation of cast metal framework of both non-precious (Ni-Cr) and noble (Au, Pt, Pd) alloys. 2. Cast restoration cementation: for preparation of intaglio surface of cast metal restorations to enhance micromechanical bonding especially of traditional cements (zinc phosphate). 3. Porcelain repair: for preparation of exposed metal (and porcelain) to repair failed porcelain fused to metal restoration…
Read the full statement (204 words)
1. Maryland Bridges (resin bonded bridges): for preparation of cast metal framework of both non-precious (Ni-Cr) and noble (Au, Pt, Pd) alloys.
2. Cast restoration cementation: for preparation of intaglio surface of cast metal restorations to enhance micromechanical bonding especially of traditional cements (zinc phosphate).
3. Porcelain repair: for preparation of exposed metal (and porcelain) to repair failed porcelain fused to metal restoration intra-orally.
4. Porcelain etch substitute: for preparation of intaglio surface of porcelain restorations in place of etching with hydrofluoric acid in the mouth.
5. Composite surface preparation substitute: for preparation of intaglio surface of composite or polymeric restoration in place of surface active agents (i.e. methyl methacrylate).
6. Composite/polymeric restoration repair: for preparation of exposed failed restoration as in 5 above.
7. Repair of acrylic facings on cast restorations: for preparation of cast metal surface to enhance bond of self-cure acrylic facing to restoration.
8. Endodontic post preparation: for preparation of endo post to enhance micromechanical bond of post to prepared tooth.
9. Denture repairs: for preparation of denture base to facilitate repairs.
10. Orthodontic applications: for preparation of ortho brackets to enhance bonding to the bracket. For cement removal from brackets before re-bonding. For enhancement of adhesive to tooth structure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970484: Accu-Prep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970484
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026