510(k) · Cleared
Recalled · Class II · 2023Statis Dental Handpieces
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scican, Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Sep 13, 2007 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 13, 2007
- Review
- 66 days
- Class
- Class I
- Product code
- EFB
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK071891 Statis Dental HandpiecesScican, Ltd. · 2007
- Descendant · cites it directly · 3 of its ownK132356 Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso…Scican GmbH · 2014
- Descendant · 2 generations on · 0 of its ownK240183 Star E900 Handpiece SeriesDentalez, Inc., Stardental Division · 2024
- Descendant · 2 generations on · 0 of its ownK230106 General Cutting StraightNakanishi, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK222518 FX ContraNakanishi, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K132356Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40STScican GmbH · 2014 · cites it directly3descendants
- K240183Star E900 Handpiece SeriesDentalez, Inc., Stardental Division · 2024 · 2 generations on0descendants
- K230106General Cutting StraightNakanishi, Inc. · 2023 · 2 generations on0descendants
- K222518FX ContraNakanishi, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071891 | Statis Dental Handpieces | Scican, Ltd. | 2007 | — |
| +1 | K132356 | Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40ST | Scican GmbH | 2014 | — |
| +2 | K240183 | Star E900 Handpiece Series | Dentalez, Inc., Stardental Division | 2024 | — |
| +2 | K230106 | General Cutting Straight | Nakanishi, Inc. | 2023 | — |
| +2 | K222518 | FX Contra | Nakanishi, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132356 | Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40ST | 2014 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 20, 2023 | Class II | Z-1208-2023 | Other | Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K132356 (Scican GmbH, 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The STATIS dental handpieces and drives are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K071891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071891: Statis Dental Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071891
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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