510(k) · Cleared
ClearedDIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SETAGAYA SEIKI Co., Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Sep 23, 2026 as substantially equivalent to K073652 (Nakamura Magnifier Co., Ltd., 2008) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Sep 23, 2026
- Review
- 90 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K935676 (1995). 28 ancestors in all, the oldest K790722 (1979). No later device cites it as a predicate yet.
- Root · 5 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 4 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 3 generations backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- 2 generations backK062812 Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B…Thunder Tiger Corp. · 2006
- 1 generation backK141886 MDK HandpiecesModern Korea Co., Ltd. · 2015
- This deviceK262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −4 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −3 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| −2 | K062812 | Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N | Thunder Tiger Corp. | 2006 | — |
| −1 | K141886 | MDK Handpieces | Modern Korea Co., Ltd. | 2015 | — |
| 0 (this device) | K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | SETAGAYA SEIKI Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1986 | 1 | 0 |
| 1990 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 K251389 High speed air turbine handpiecescore 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K073652 | ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight…Summary page 5…Dental Handpiece and Accessories Class: I Primary Predicate Clearance: K073652, 03/20/2008 Device: Manufacturer: NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.… | 2008 |
| * | K141886 | MDK HandpiecesSummary page 5…Dental Handpiece and Accessories Class: I Secondary Clearance: K141886, 05/13/2015 Predicate Device: Manufacturer: Modern Korea Co., Ltd Trade Name:… | 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 31 years and passes through 5 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 28 ancestors has a recall of any class.
- 2 other devices also cite its predicate K073652.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
DIAMED Handpiece is intended for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable. DIAMED Airmotor is used to power various attachments which helps dental clinician perform various dental procedures. All the devices are autoclavable. DIAMED Airmotor Handpiece is an…
Read the full statement (93 words)
DIAMED Handpiece is intended for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable.
DIAMED Airmotor is used to power various attachments which helps dental clinician perform various dental procedures. All the devices are autoclavable.
DIAMED Airmotor Handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262144: DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262144
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026