510(k) · Cleared
ClearedTRAUS Air Dental Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saeshin Precision Co., Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Feb 22, 2023 as substantially equivalent to K141576 (Kavo DO Brasil Industria E Comercio Ltda, 2015) after a 252-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Feb 22, 2023
- Review
- 252 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K935676 (1995). 13 ancestors in all, the oldest K760794 (1976). No later device cites it as a predicate yet.
- Root · 7 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 6 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 5 generations backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- 4 generations backK062740 Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 2006
- 3 generations backK101717 Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam…Aerobine, Inc. · 2010
- 2 generations backK112024 TI-Max X450Nakanishi, Inc. · 2012
- 1 generation backK141576 Maxima PRO 45LKavo DO Brasil Industria E Comercio Ltda · 2015
- This deviceK221741 TRAUS Air Dental HandpieceSaeshin Precision Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −6 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −5 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| −4 | K062740 | Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU | Jindell Medical Instruments Co., Ltd. | 2006 | — |
| −3 | K101717 | Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor… | Aerobine, Inc. | 2010 | — |
| −2 | K112024 | TI-Max X450 | Nakanishi, Inc. | 2012 | — |
| −1 | K141576 | Maxima PRO 45L | Kavo DO Brasil Industria E Comercio Ltda | 2015 | — |
| 0 (this device) | K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K141576 | Maxima PRO 45LSummary page 5…se by a trained professional in the field of general dentistry. Predicate Device: Manufacturer: KaVo do Brasil Industria e Comercio Ltda 510(k) Number: K141576 Trade Name: Maxima PRO 45L Common Name: Handpiece, Air-Powered, Dental Regulation Name: Dental handpiece and accessories Regulati… | 2015 |
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 28 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- None of the 13 ancestors has a recall.
- 2 other devices also cite its predicate K141576.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
What is it indicated for?
This air-powered dental handpiece is intended for removal of carious material, cavities and crown preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures.
It is designed for use by a trained professional in the field of general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221741: TRAUS Air Dental Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221741
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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