510(k) · Cleared
ClearedDental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Topmed Dental Co., Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Jan 12, 2026 as substantially equivalent to K170236 (Guangdong Jinme Medical Technology Co., Ltd., 2017) and 2 other predicates after a 252-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jan 12, 2026
- Review
- 252 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K935676 (1995). 30 ancestors in all, the oldest K863677 (1986). 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 deviceK251388 Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4…Foshan Topmed Dental 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) | K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS… | Foshan Topmed Dental Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 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? (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 | Decided |
|---|---|---|---|
| * | K170236 | Dental Low-speed Turbine HandpieceSummary page 5…otor handpiece Model：TM-203B2、TM-203M4、TM-205B2、TM-205M4、TM-IS、TM-ES、 TM-SG20、TM-X25、TM-BB、TM-IC、TM-RA41 3. Predicate Device 1 Information: 510(k) Number: K170236 Device Classification Name: Dental Sponsor: Guangdong JINME Medical Technology Co., Ltd. Classification Product Code:… | 2017 |
| * | K150798 | Codent Low Speed Dental Handpieces and AccessoriesSummary page 6… Trade/Proprietary Name: Dental Low-speed Turbine Handpiece Common Name: Dental Handpiece 4. Predicate Device 2 Information: 510(k) Number: K150798 Device Classification Name: Dental Sponsor: Codent Technical Industry Co., Ltd. Classification Product Code: EFB、EGS… | 2015 |
| * | K141886 | MDK HandpiecesSummary page 6… Trade/Proprietary Name: Codent Low Speed Dental Handpieces and Accessories Common Name: Dental Handpiece 5. Predicate Device 3 Information: 510(k) Number: K141886 Device Classification Name: Dental Sponsor: MODERN KOREA Co., Ltd. Classification Product Code: EFB Regulation Nu… | 2015 |
| † | K163483 | PANA SPRAY Plus | 2017 |
| † | K052700 | Pana-Spray | 2005 |
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 30 ancestors has a recall of any class.
- 1 other device also cites its predicate K170236.
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?
Dental air motor handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251388: Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251388
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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