510(k) · Cleared
ClearedTRAUS 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 Nov 26, 2019 as substantially equivalent to K171436 (Saeshin Precision Co., Ltd., 2018) after a 407-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Nov 26, 2019
- Review
- 407 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K971350 (1997). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 5 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 4 generations backK092412 Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009
- 3 generations backK100192 Strong Dental HandpiecesSaeshin Precision Co., Ltd. · 2010
- 2 generations backK143418 STRONG Dental HandpiecesSaeshin Precision Co., Ltd. · 2015
- 1 generation backK171436 STRONG Dental HandpiecesSaeshin Precision Co., Ltd. · 2018
- This deviceK182892 TRAUS Dental HandpiecesSaeshin Precision Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −5 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −4 | K092412 | Strong Implant Handpieces | Saeshin Precision Co., Ltd. | 2009 | — |
| −3 | K100192 | Strong Dental Handpieces | Saeshin Precision Co., Ltd. | 2010 | — |
| −2 | K143418 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2015 | — |
| −1 | K171436 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2018 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K171436 | STRONG Dental HandpiecesSummary page 5…ification of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follows: 510(k) Number: K171436 Applicant: Saeshin Precision Co., Ltd. Common Name: Dental Handpieces and Accessories… | 2018 |
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 22 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 8 ancestors has a recall.
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. 2019, 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 TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN 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/K182892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182892: TRAUS 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/K182892
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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