510(k) Report

510(k) · Cleared

Cleared

Schein AP-1 Air Polishing Unit

K862384510(k) TraditionalCleared Nov 7, 1986136-day reviewClass II21 CFR 872.6080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Henry Schein, Inc. · KOJ Airbrush

Cleared on Nov 7, 1986 after a 136-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 7, 1986
Review
136 days
Class
Class II
Product code
KOJ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K862384Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K251425 turbodent touchscore 11.1 · 7 generations · no Class I recall
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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 devices

KOJ Airbrush: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KOJ

1in 2025

2007: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

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

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KOJ

2in 2025

2007: 12008: 22009: 32010: 32011: 22012: 12015: 22017: 12025: 2
2007high 3 (2009) · low 0 (2013)2025

MAUDE reports naming product code KOJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20080—02
20090—03
20100—13
20110—02
20120—01
20130—00
20140—00
20150—02
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20251—02
20260—0—

More from Henry Schein, Inc.

8 FDA decisions under this applicant name. See the company

  • K041580ImagerayiHenry Schein, Inc. · 2004
  • K862385Schein Bleaching UnitHenry Schein, Inc. · 1986
  • K841199Fiberglass Mouth MirrorsHenry Schein, Inc. · 1984
  • K834055Vanadium Excavators Sizes 0-6Henry Schein, Inc. · 19848 recalls
  • K834056Schein Cotton Rolls, Non-SterileHenry Schein, Inc. · 1984

Recent decisions in KOJ

The KOJ category page

  • K251425turbodent touchMectron S.P.A. · 2025
  • K063236Beta-PowderBrainbase Corporation · 2007
  • K042872Rondoflex Plus 360Kavo America Corporation · 2004
  • K033675Prosmile Air Polisher and Prophylaxis PowderSirona Dental Systems GmbH · 2004
  • K033215PrepairDanville Materials, Inc. · 2004

https://510kreport.com/device/K862384 · printed Nov 4, 2026

Cite this page

510(k) Report. “K862384: Schein AP-1 Air Polishing Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862384

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026