510(k) · Cleared
ClearedStrong Dental Handpieces
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saeshin Precision Co., Ltd. · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Feb 4, 2010 as substantially equivalent to K011061 (W&H Dentalwerk Buermoos GmbH, 2001) and 1 other predicate after a 13-day review. Its family tree reaches back 3 generations to 1997. 3 later devices descend from it.
- Decided
- Feb 4, 2010
- Review
- 13 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971350 (1997). 5 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 2 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 1 generation backK092412 Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009
- This deviceK100192 Strong Dental HandpiecesSaeshin Precision Co., Ltd. · 2010
- Descendant · cites it directly · 2 of its ownK143418 STRONG Dental HandpiecesSaeshin Precision Co., Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK171436 STRONG Dental HandpiecesSaeshin Precision Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK182892 TRAUS Dental HandpiecesSaeshin Precision Co., Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −2 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −1 | K092412 | Strong Implant Handpieces | Saeshin Precision Co., Ltd. | 2009 | — |
| 0 (this device) | K100192 | Strong Dental Handpieces | Saeshin Precision Co., Ltd. | 2010 | — |
| +1 | K143418 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2015 | — |
| +2 | K171436 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2018 | — |
| +3 | K182892 | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 EGS? 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 EGS device
- #1 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 1 generation · 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 |
|---|---|---|---|
| * | K011061 | Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight… | 2001 |
| * | K092412 | Strong Implant HandpiecesSummary page 1…ental 3. Predicate Device: * Surgical Contra-Angle Handpieces Types WS-56E, Surgical straight Handpieces Types, S- Il, KO 11061 * STRONG Implant Handpieces, K092412 4. Classifications Names & Citations: EGS, 872.4200 5. Description: The STRONG Dental Handpieces; AT-Il, ACL-0IC, A… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143418 | STRONG Dental Handpieces | 2015 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K143418 (Saeshin Precision Co., Ltd., 2015) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K011061.
How does its category compare?
All EGS devicesEGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · EGS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGS
189in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGS
82in 2025
MAUDE reports naming product code EGS, 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 | 2 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 1 | — | 0 | 45 |
| 2010 | 2 | — | 0 | 74 |
| 2011 | 3 | 104 | 0 | 2 |
| 2012 | 3 | 288 | 0 | 3 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 38 |
| 2015 | 3 | 245 | 0 | 166 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 2 | — | 0 | 316 |
| 2018 | 1 | — | 0 | 230 |
| 2019 | 3 | 276 | 0 | 219 |
| 2020 | 1 | — | 0 | 191 |
| 2021 | 1 | — | 0 | 294 |
| 2022 | 4 | 189 | 0 | 279 |
| 2023 | 1 | — | 1 | 115 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 82 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The STRONG Dental Handpieces is indicated for wide range of dental procedures.
AT- II for the application in the area of the front teeth, root tip resection, bone removal, osteotomia. on the upper and lowerjaw, preprosthetic surgical modellation, sequestrotomia, fenestration on the alveolar appendix, apicall ventilation, bone modellation, bone smoothing.
ACL-0 1, ACL(B)-O I C and ACL-02C for the osteotomia on the upper and lower jaw, germectomia, sequestrotomnia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100192: Strong Dental Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100192
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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