510(k) · Cleared
ClearedSeries XE, Series SE, Series TE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Mega Societe Anonyme · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Jun 4, 1997 after a 55-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 27 later devices descend from it.
- Decided
- Jun 4, 1997
- Review
- 55 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 1 citing it directly.
- This deviceK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- Descendant · cites it directly · 26 of its ownK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- Descendant · 2 generations on · 15 of its ownK092412 Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009
- Descendant · 3 generations on · 10 of its ownK111616 E-CUBESaeshin Precision Co., Ltd. · 2011
- Descendant · 4 generations on · 6 of its ownK133298 Endo SmartMeta Biomed, Inc. · 2014
- Descendant · 5 generations on · 5 of its ownK153285 EMS-200Meta Systems Co., Ltd. · 2016
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K040674Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra AnglesAnthogyr · 2004 · cites it directly26descendants
- K092412Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009 · 2 generations on15descendants
- K111616E-CUBESaeshin Precision Co., Ltd. · 2011 · 3 generations on10descendants
- K133298Endo SmartMeta Biomed, Inc. · 2014 · 4 generations on6descendants
- K153285EMS-200Meta Systems Co., Ltd. · 2016 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K092412 | Strong Implant Handpieces | Saeshin Precision Co., Ltd. | 2009 | — |
| +3 | K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 2011 | — |
| +4 | K133298 | Endo Smart | Meta Biomed, Inc. | 2014 | — |
| +5 | K153285 | EMS-200 | Meta Systems Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra Angles | 2004 | 26 |
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?
- Of its descendants, K040674 (Anthogyr, 2004) has gone furthest, with 26 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.
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?
These contra-angles are intended for use on dental motors equipped with a-coupling according to ISO-Standard 3964.
The speed of the motors may not exceed 40 000 RPM.
These contra-angles may receive all dental instruments for contra-angles (burs, prophylaxis instruments, endodontic instruments) whose shank is of type 1, such as determined in ISO Standard 1797.
They allow to carry out all low speed dental works
Their usage is of course reserved to dentists or hygienists who are duly graduated and entitled to exercise.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971350: Series XE, Series SE, Series TE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971350
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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