510(k) · Cleared
ClearedDental Handpiece, Model CA160, CA160L, and CA500L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Nx Co., Ltd. · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Jul 29, 2022 as substantially equivalent to K192809 (Micro-Nx Co., Ltd., 2020) after a 151-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Jul 29, 2022
- Review
- 151 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K971350 (1997). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 3 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 2 generations backK093894 Anthogyr Impulsion Implantology Contra-AngleAnthogyr · 2010
- 1 generation backK192809 Dental HandpieceMicro-Nx Co., Ltd. · 2020
- This deviceK220577 Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK232810 Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −3 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −2 | K093894 | Anthogyr Impulsion Implantology Contra-Angle | Anthogyr | 2010 | — |
| −1 | K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | 2020 | — |
| 0 (this device) | K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | 2022 | — |
| +1 | 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 |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K192809 | Dental HandpieceSummary page 4…ory Class: Class I • Traditional 510(k) Registration Prior formal correspondence with the FDA resulted in the 510(k) clearance of the Micro-NX Dental Handpiece(K192809) with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R. Ⅲ. PREDICATE DEVICES • Predicate Device: Dental Handpie… | 2020 |
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 |
|---|---|---|---|
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | 2023 | 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 25 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K232810 (Micro-Nx Co., Ltd., 2023) 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. 2022, 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 Dental Handpiece with models of CAl60, CAl60L, and CA500L 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.
The 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/K220577 · printed Nov 3, 2026
Cite this page
510(k) Report. “K220577: Dental Handpiece, Model CA160, CA160L, and CA500L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K220577
Report an extraction error
Are you the manufacturer?
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