510(k) · Cleared
ClearedDental Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Nx Co., Ltd. · EFA Handpiece, Belt And/Or Gear Driven, Dental
Cleared on Aug 25, 2020 as substantially equivalent to K163239 (Kaltenbach & Voigt GmbH, 2017) and 1 other predicate after a 329-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- Aug 25, 2020
- Review
- 329 days
- Class
- Class I
- Product code
- EFA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971350 (1997). 7 ancestors in all. 2 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 backK093894 Anthogyr Impulsion Implantology Contra-AngleAnthogyr · 2010
- This deviceK192809 Dental HandpieceMicro-Nx Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK220577 Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK232810 Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · 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 | K093894 | Anthogyr Impulsion Implantology Contra-Angle | Anthogyr | 2010 | — |
| 0 (this device) | K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | 2020 | — |
| +1 | K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | 2022 | — |
| +2 | K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 EFA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K163239 | SMARTmaticSummary page 4…istration (There were no prior submissions for the proposed, Micro-NX Dental Handpiece, which is labeled for 5 year shelf life) Ⅲ. PREDICATE DEVICES • SMARTmatic (K163239), Manufacturer: Kaltenbach & Voigt GmbH • Anthogyr Contra Angles and Handpieces (K093894), Manufacturer: Anthogyr Th… | 2017 |
| * | K093894 | Anthogyr Impulsion Implantology Contra-AngleSummary page 4…is labeled for 5 year shelf life) Ⅲ. PREDICATE DEVICES • SMARTmatic (K163239), Manufacturer: Kaltenbach & Voigt GmbH • Anthogyr Contra Angles and Handpieces (K093894), Manufacturer: Anthogyr These predicate devices have not been subject to a design-related recall.… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | 2022 | 1 |
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 23 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K220577 (Micro-Nx Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
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. 2020, 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?
Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the
removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations,
removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating
the bone, tapping and threading procedures.
Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192809 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192809: Dental Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192809
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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