510(k) · Cleared

Cleared

Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6

K980216510(k) TraditionalCleared Jun 16, 1998146-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 16, 1998 as substantially equivalent to K940776 (Kreativ, Inc., 1994) and 2 other predicates after a 146-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.

Decided: Jun 16, 1998
Review: 146 days
Class: Class II
Product code: KOJ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K921748 (1992). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK921748 Model 2000 Dental Air Abrasive SystemTexas Airsonics, Inc. · 1992
This deviceK980216 Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6Kreativ, Inc. · 1998
Descendant · cites it directly · 0 of its ownK990060 MACH 7Kreativ, Inc. · 2000
Descendant · cites it directly · 0 of its ownK984415 S.S. White Technologies, Models 6500-D,6500-E, and 6500-FS.S. White Technologies, Inc. · 1999

Most influential descendants

Showing 2 of 2 · See all

K990060MACH 7Kreativ, Inc. · 2000 · cites it directly0descendants
K984415S.S. White Technologies, Models 6500-D,6500-E, and 6500-FS.S. White Technologies, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921748	Model 2000 Dental Air Abrasive System	Texas Airsonics, Inc.	1992	—
0 (this device)	K980216	Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6	Kreativ, Inc.	1998	—
+1	K990060	MACH 7	Kreativ, Inc.	2000	—
+1	K984415	S.S. White Technologies, Models 6500-D,6500-E, and 6500-F	S.S. White Technologies, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0

FIG. 1 — Lineage of K980216, 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
*	K940776	Kreativ Model KV-1 Summary page 1 …rs Jeff Lane Kreativ, Inc. 1517 Industrial Way. SW Albany, OR 97321 Phone: 541/924 2480 Device Name: Mach 5, Mach 5 plus, Mach M, and Mach 6 Predicate Devices: KV 1, K#940776 (Kreativ, Inc., Albany, OR), KCP 2000, K#921748 (American Dental Technologies, Troy, MI). and the MicroPrep Cavity Preparation Sy…	Kreativ, Inc.	1994	—
*	K921748	Model 2000 Dental Air Abrasive System Summary page 1 …SW Albany, OR 97321 Phone: 541/924 2480 Device Name: Mach 5, Mach 5 plus, Mach M, and Mach 6 Predicate Devices: KV 1, K#940776 (Kreativ, Inc., Albany, OR), KCP 2000, K#921748 (American Dental Technologies, Troy, MI). and the MicroPrep Cavity Preparation System, K#932997, (Sunrise Technologies, Inc.). D…	Texas Airsonics, Inc.	1992	—
*	K932997	Microprep Cavity Preperation System Summary page 1 …redicate Devices: KV 1, K#940776 (Kreativ, Inc., Albany, OR), KCP 2000, K#921748 (American Dental Technologies, Troy, MI). and the MicroPrep Cavity Preparation System, K#932997, (Sunrise Technologies, Inc.). Device and Indications for use: The Mach 5, Mach 5 plus, Mach M, and Mach 6 are pneumatic devices…	Sunrise Technologies, Inc.	1994	—

Also cleared against K940776: 2 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K990060	MACH 7	Kreativ, Inc.	2000	0
K984415	S.S. White Technologies, Models 6500-D,6500-E, and 6500-F	S.S. White Technologies, Inc.	1999	0

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 3 ancestors has a recall.
Of its descendants, K990060 (Kreativ, Inc., 2000) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K940776.

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 Series Air Abrasion systems are used for cavity preparation in Classes I, I, III, 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 percelain and ceramic. They are also 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/K980216 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980216: Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980216

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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