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 Jan 5, 2018 as substantially equivalent to K143418 (Saeshin Precision Co., Ltd., 2015) and 1 other predicate after a 234-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Jan 5, 2018
- Review
- 234 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K971350 (1997). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 4 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 3 generations backK092412 Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009
- 2 generations backK100192 Strong Dental HandpiecesSaeshin Precision Co., Ltd. · 2010
- 1 generation backK143418 STRONG Dental HandpiecesSaeshin Precision Co., Ltd. · 2015
- This deviceK171436 STRONG Dental HandpiecesSaeshin Precision Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK182892 TRAUS Dental HandpiecesSaeshin Precision Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K182892TRAUS Dental HandpiecesSaeshin Precision Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −4 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −3 | K092412 | Strong Implant Handpieces | Saeshin Precision Co., Ltd. | 2009 | — |
| −2 | K100192 | Strong Dental Handpieces | Saeshin Precision Co., Ltd. | 2010 | — |
| −1 | K143418 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2015 | — |
| 0 (this device) | K171436 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2018 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K143418 | STRONG Dental HandpiecesSummary page 5…ation of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follows: · 510(k) Number: K143418 · Applicant: Saeshin Precision Co., Ltd. · Common Name: Dental Handpieces and Accesso… | 2015 |
| * | K092412 | Strong Implant HandpiecesSummary page 11…ents of chuck, head and nozzle were totally same and have been previously cleared by FDA through STRONG Implant H a n d p i e c e s ( K 0 9 2 4 1 2 ) of predicate device, STRONG Dental Handpiece. The b i o c o m p a t i b i l i t y test report has been issued by Korea Testi… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182892 | TRAUS Dental Handpieces | 2019 | 0 |
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 21 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K182892 (Saeshin Precision Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
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. 2018, 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, ACL(B)-611, ACL(B)-62I, ACL(B)-631, ACL(B)-65I and ACL(B)-04C are intended
for a wide range of dental procedures including:
A. Implant placement, including
1. Preparation of the osteotomy site
2. Bone contouring, osteoplasty
B. Periodontal surgeries
1. Bone contouring & alveoplasty around living teeth
2. Removal of exostosis
C. Bone grafting
1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
2. Harvesting autogen living bone
3. Sinus elevation & grafting of alveolar sockets
D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
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/K171436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171436: 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/K171436
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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