510(k) · Cleared

Cleared

MACH 7

K990060510(k) TraditionalCleared Jun 15, 2000524-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 Jun 15, 2000 as substantially equivalent to K921748 (Texas Airsonics, Inc., 1992) and 2 other predicates after a 524-day review. Its family tree reaches back 2 generations to 1992.

Decided: Jun 15, 2000
Review: 524 days
Class: Class II
Product code: KOJ
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K921748 (1992). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK921748 Model 2000 Dental Air Abrasive SystemTexas Airsonics, Inc. · 1992
1 generation backK980216 Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6Kreativ, Inc. · 1998
This deviceK990060 MACH 7Kreativ, Inc. · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K921748	Model 2000 Dental Air Abrasive System	Texas Airsonics, Inc.	1992	—
−1	K980216	Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6	Kreativ, Inc.	1998	—
0 (this device)	K990060	MACH 7	Kreativ, Inc.	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0

FIG. 1 — Lineage of K990060, 1992–2000Source: 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? (3)

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
*	K921748	Model 2000 Dental Air Abrasive System Summary page 1 …San Diego, CA. 92123 Company Contact: Joe Forehand Kreativ, Inc. 9025 Balboa Ave. San Diego, CA. 92123 (619) 514-4235 Nevice Name: Mach 7 Predicate Devices: KCP 2000 K921748 American Dental Technologies MicroPrep K932997 Sunrise Technologies Mach 5 K980216 Kreativ, Inc. Mach 6 K980216 Kreativ, Inc. De…	Texas Airsonics, Inc.	1992	—
*	K932997	Microprep Cavity Preperation System Summary page 1 …ehand Kreativ, Inc. 9025 Balboa Ave. San Diego, CA. 92123 (619) 514-4235 Nevice Name: Mach 7 Predicate Devices: KCP 2000 K921748 American Dental Technologies MicroPrep K932997 Sunrise Technologies Mach 5 K980216 Kreativ, Inc. Mach 6 K980216 Kreativ, Inc. Device and indications for use: The Mach 7 is an…	Sunrise Technologies, Inc.	1994	—
*	K980216	Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6 Summary page 1 …San Diego, CA. 92123 (619) 514-4235 Nevice Name: Mach 7 Predicate Devices: KCP 2000 K921748 American Dental Technologies MicroPrep K932997 Sunrise Technologies Mach 5 K980216 Kreativ, Inc. Mach 6 K980216 Kreativ, Inc. Device and indications for use: The Mach 7 is an air abrasion pneumatic device which…	Kreativ, Inc.	1998	—

Also cleared against K921748: 3 other devices →

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?

The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
None of the 4 ancestors has a recall.
3 other devices also cite its predicate K921748.

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 Kreativ Mach 7 Air Abrasion system is used for cavity preparation in Classes [, I, HI, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. It may also be used for restoration prophylaxis.

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/K990060 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990060: MACH 7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990060

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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