510(k) · Cleared
ClearedStrong Implant Handpieces
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saeshin Precision Co., Ltd. · EFA Handpiece, Belt And/Or Gear Driven, Dental
Cleared on Sep 3, 2009 as substantially equivalent to K040674 (Anthogyr, 2004) after a 28-day review. Its family tree reaches back 2 generations to 1997. 15 later devices descend from it.
- Decided
- Sep 3, 2009
- Review
- 28 days
- Class
- Class I
- Product code
- EFA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971350 (1997). 3 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 1 generation backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- This deviceK092412 Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009
- Descendant · cites it directly · 10 of its ownK111616 E-CUBESaeshin Precision Co., Ltd. · 2011
- Descendant · 2 generations on · 6 of its ownK133298 Endo SmartMeta Biomed, Inc. · 2014
- Descendant · 3 generations on · 5 of its ownK153285 EMS-200Meta Systems Co., Ltd. · 2016
- Descendant · 4 generations on · 4 of its ownK202906 EndoPilot2Schlumbohm GmbH & Co. KG · 2021
- Descendant · cites it directly · 3 of its ownK100192 Strong Dental HandpiecesSaeshin Precision Co., Ltd. · 2010
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K111616E-CUBESaeshin Precision Co., Ltd. · 2011 · cites it directly10descendants
- K133298Endo SmartMeta Biomed, Inc. · 2014 · 2 generations on6descendants
- K153285EMS-200Meta Systems Co., Ltd. · 2016 · 3 generations on5descendants
- K202906EndoPilot2Schlumbohm GmbH & Co. KG · 2021 · 4 generations on4descendants
- K100192Strong Dental HandpiecesSaeshin Precision Co., Ltd. · 2010 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −1 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| 0 (this device) | K092412 | Strong Implant Handpieces | Saeshin Precision Co., Ltd. | 2009 | — |
| +1 | K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 2011 | — |
| +2 | K133298 | Endo Smart | Meta Biomed, Inc. | 2014 | — |
| +3 | K153285 | EMS-200 | Meta Systems Co., Ltd. | 2016 | — |
| +4 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 | — |
| +1 | K100192 | Strong Dental Handpieces | Saeshin Precision Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 EFA? 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 EFA device
- #1 K192809 Dental Handpiecescore 3.5 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra AnglesSummary page 1…eces Commaon Name- Dental H1andpiece Classification Name- Handpiece, Gear-Driven, Dental 3. Predicate Device: ANTHOGYR Contra Angles and Handpieces, K040674 4. Classifications.Names & Citations: EFAS 872,4200 5. Description.: The STRONG Implant Handpieces; ACL-41L ACL(B… | 2004 |
What descends from it? (15)
See all 153 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K111616 (Saeshin Precision Co., Ltd., 2011) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K040674.
How does its category compare?
All EFA devicesEFA Handpiece, Belt And/Or Gear Driven, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EFA
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · EFA
78in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFA
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EFA
4in 2025
MAUDE reports naming product code EFA, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 4 | 78 | 0 | 0 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The STRONG Implant Handpieces, ACL-411, ACL(B)-411, ACL-421, ACL(B)-421, ACL-431, ACL(B)-431, ACL-451 and ACL(B)-451, are devices intended for a wide range of dental procedures including:
* Endodontic surgeries, such as root canal preparations
* Implant surgery such as perforating the bone, tapping and threading procedures
* General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restorations and polishing teeth
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/K092412 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092412: Strong Implant Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092412
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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