510(k) · Cleared

Cleared

Prepair

K033215510(k) TraditionalCleared Jan 9, 200498-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

Cleared on Jan 9, 2004 as substantially equivalent to K970589 (Danville Engineering, Inc., 1997) and 3 other predicates after a 98-day review. Its family tree reaches back 1 generation to 1997.

Decided: Jan 9, 2004
Review: 98 days
Class: Class II
Product code: KOJ
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K970589 (1997). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK970589 Microetcher APDanville Engineering, Inc. · 1997
This deviceK033215 PrepairDanville Materials, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970589	Microetcher AP	Danville Engineering, Inc.	1997	—
0 (this device)	K033215	Prepair	Danville Materials, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
2000	1	0

FIG. 1 — Lineage of K033215, 1997–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K970589	Microetcher AP Summary page 1 …The device is substantially equivalent to other legally marketed devices in the United States including PrepStart by Danville Engineering (K970589), PrepTech by Prep Technology Corp (K974655), AirDent by Air Techniques (K981564)…	Danville Engineering, Inc.	1997	—
*	K974655	Preptech (TM) 200 Cavity Preparation System Summary page 1 …ted devices in the United States including PrepStart by Danville Engineering (K970589), PrepTech by Prep Technology Corp (K974655), AirDent by Air Techniques (K981564) and Rondoflex by Kavo America (K002708). Intended Use T…	Prep Technology Corp.	1998	—
*	K981564	Air Techniques' Airdent II Summary page 1 …uding PrepStart by Danville Engineering (K970589), PrepTech by Prep Technology Corp (K974655), AirDent by Air Techniques (K981564) and Rondoflex by Kavo America (K002708). Intended Use The PrepAir is intended for the cutting and preparation of all…	Air Techniques, Inc.	1998	—
*	K002708	Kavo Corund Handpiece 2013 Summary page 1 …(K970589), PrepTech by Prep Technology Corp (K974655), AirDent by Air Techniques (K981564) and Rondoflex by Kavo America (K002708). Intended Use The PrepAir is intended for the cutting and preparation of all classes of cavity…	Kavo America	2000	—

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.

What does this lineage say?

None of the 4 ancestors has a 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

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

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

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

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?

The PrepAir is intended for the cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033215 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033215: Prepair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033215

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026