510(k) · Cleared
ClearedDental Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North West Medical Instrument (Group) Co., Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Apr 22, 2010 as substantially equivalent to K070155 (Osseo Scientific, LLC, 2007) and 1 other predicate after a 119-day review. Its family tree reaches back 5 generations to 1976.
- Decided
- Apr 22, 2010
- Review
- 119 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K760929 (1976). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK760929 Accutorq IIRitter Co. · 1976
- 4 generations backK021250 MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012…Handpiece Unlimited · 2002
- 3 generations backK032234 MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K…Mk-Dent GmbH · 2003
- 2 generations backK051872 MK-Dent Low Speed Handpieces and Accessories Including Spare Parts…Mk-Dent GmbH · 2005
- 1 generation backK070155 Integrity Low Speed Dental Air Handpiece and Attachment, Models…Osseo Scientific, LLC · 2007
- This deviceK093971 Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K760929 | Accutorq II | Ritter Co. | 1976 | — |
| −4 | K021250 | MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard… | Handpiece Unlimited | 2002 | — |
| −3 | K032234 | MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS… | Mk-Dent GmbH | 2003 | — |
| −2 | K051872 | MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings… | Mk-Dent GmbH | 2005 | — |
| −1 | K070155 | Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E… | Osseo Scientific, LLC | 2007 | — |
| 0 (this device) | K093971 | Dental Handpiece | North West Medical Instrument (Group) Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K070155 | Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor…Summary page 3…icual in greneal dientListry, 5. Substantially Equivalence Determination Predicate Device a. INTEGRITY Low Speed Den Hi-Speed Turbine Handpiece K-number: K0701 55 Manufactured by: Osseo Scientific, LLC… | 2007 |
| * | K071561 | HI-Speed Turbine Handpieces, Model GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-DSummary page 4…111-3 Premarket Notification 510(k) Chapter III 510(k) Summary Repon No.: 20081 110 b. Hi-Speed Turbine Handpiece K-number: K071561 Manufactured by: Beijing North Pole Dental H-andpiece Co., Ltd. The applicant devices are substantially equivalent t… | 2007 |
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 34 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 15 ancestors has a recall.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.
This device is an air-powered hand-held device, intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and polishing teeth for use by a trained professional in general dentistry.
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/K093971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093971: 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/K093971
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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