510(k) · Cleared

Cleared

Air Solfy, Models as-4H, as-4H-O, as-4H-V, as-4H-OV, as-1,as-1-0,as-1-V, as-1-OV

K043497510(k) TraditionalCleared Mar 21, 200594-day reviewClass I21 CFR 872.4200

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

J. Morita USA, Inc. · EFB Handpiece, Air-Powered, Dental

Cleared on Mar 21, 2005 as substantially equivalent to K033812 (Sirona Dental Systems GmbH, 2004) after a 94-day review. Its family tree reaches back 2 generations to 1995.

Decided: Mar 21, 2005
Review: 94 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K944714 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK944714 W&H Corsair ScalerA-Dec, Inc. · 1995
1 generation backK033812 Siroair L Air ScalerSirona Dental Systems GmbH · 2004
This deviceK043497 Air Solfy, Models as-4H, as-4H-O, as-4H-V, as-4H-OV…J. Morita USA, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K944714	W&H Corsair Scaler	A-Dec, Inc.	1995	—
−1	K033812	Siroair L Air Scaler	Sirona Dental Systems GmbH	2004	—
0 (this device)	K043497	Air Solfy, Models as-4H, as-4H-O, as-4H-V, as-4H-OV, as-1,as-1-0,as-1-V, as-1-OV	J. Morita USA, Inc.	2005	—

FIG. 1 — Lineage of K043497, 1995–2005Source: 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 EFB? 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 EFB device

#1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K033812	Siroair L Air Scaler Summary page 2 …ir Solfy is substantially equivalent to the general scaler from Sirona dental syatem , Inc(K#033812). Air Solfy has similar characteristics as intended us…	Sirona Dental Systems GmbH	2004	—

Also cleared against K033812: 1 other device →

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 10 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K033812.

How does its category compare?

All EFB devices

EFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFB

1in 2025

2007high 12 (2007) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFB

209in 2024

2007high 430 (2022) · low 61 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EFB

No recall names EFB since 2007.

Adverse event reports per year · EFB

83in 2025

2007high 157 (2022) · low 13 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	12	61	13
2008	7	97	19
2009	11	120	40
2010	8	116	78
2011	4	168	96
2012	8	130	97
2013	3	207	61
2014	7	200	73
2015	7	296	87
2016	3	205	122
2017	7	246	153
2018	3	210	81
2019	3	348	117
2020	5	259	94
2021	2	—	123
2022	5	430	157
2023	4	158	116
2024	5	209	104
2025	1	—	83
2026	4	252	—

What is it indicated for?

The Air Solfy is a dental air-powered handpiece scaler and tips that can remove calculus deposits from the teeth by application of an air-powered vibrating scaler tip to the teeth during dental cleaning and periodontal therapy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043497 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043497: Air Solfy, Models as-4H, as-4H-O, as-4H-V, as-4H-OV, as-1,as-1-0,as-1-V, as-1-OV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043497

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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