510(k) · Cleared
ClearedEQ-M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meta Systems Co., Ltd. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Sep 21, 2022 as substantially equivalent to K112665 (J. Morita USA, Inc., 2012) after a 581-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Sep 21, 2022
- Review
- 581 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K951425 (1995). 14 ancestors in all, the oldest K921979 (1993). No later device cites it as a predicate yet.
- Root · 7 generations backK951425 Spectrum Curing Light Polymerization UnitDentsply Intl. · 1995
- 6 generations backK982318 Spectrum 800 Curing UnitDentsply Intl. · 1998
- 5 generations backK031615 Sled Curing Light SystemDentsply International · 2003
- 4 generations backK041372 Smartlite PS Pen-Style Led Curing LightDentsply International · 2004
- 3 generations backK063529 Pencure, Model VL-7J. Morita USA, Inc. · 2007
- 2 generations backK071190 Root ZX IIJ. Morita USA, Inc. · 2007
- 1 generation backK112665 Tri Auto Mini - Endodeontic Treatment Motorized HandpieceJ. Morita USA, Inc. · 2012
- This deviceK210475 EQ-MMeta Systems Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | 1995 | — |
| −6 | K982318 | Spectrum 800 Curing Unit | Dentsply Intl. | 1998 | — |
| −5 | K031615 | Sled Curing Light System | Dentsply International | 2003 | — |
| −4 | K041372 | Smartlite PS Pen-Style Led Curing Light | Dentsply International | 2004 | — |
| −3 | K063529 | Pencure, Model VL-7 | J. Morita USA, Inc. | 2007 | — |
| −2 | K071190 | Root ZX II | J. Morita USA, Inc. | 2007 | — |
| −1 | K112665 | Tri Auto Mini - Endodeontic Treatment Motorized Handpiece | J. Morita USA, Inc. | 2012 | — |
| 0 (this device) | K210475 | EQ-M | Meta Systems Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 EKX? 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 EKX device
- #1 K261987 Reusable SmartPegscore 13.2 · 5 generations · 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.
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 27 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 14 ancestors has a recall.
How does its category compare?
All EKX devicesEKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · EKX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EKX
244in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EKX
No recall names EKX since 2007.
Adverse event reports per year · EKX
9in 2025
MAUDE reports naming product code EKX, 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 | 9 |
| 2008 | 3 | 101 | 0 | 10 |
| 2009 | 4 | 186 | 0 | 11 |
| 2010 | 3 | 114 | 0 | 20 |
| 2011 | 4 | 75 | 0 | 6 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 2 | — | 0 | 45 |
| 2014 | 3 | 251 | 0 | 102 |
| 2015 | 3 | 178 | 0 | 68 |
| 2016 | 3 | 274 | 0 | 66 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 3 | 293 | 0 | 49 |
| 2019 | 3 | 349 | 0 | 56 |
| 2020 | 1 | — | 0 | 67 |
| 2021 | 5 | 214 | 0 | 79 |
| 2022 | 3 | 359 | 0 | 37 |
| 2023 | 4 | 152 | 0 | 14 |
| 2024 | 4 | 276 | 0 | 19 |
| 2025 | 5 | 244 | 0 | 9 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The EQ-M motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points. When connected to Apex locator (EQ-PEX), the EQ-M can be used to measure the length of root canals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210475: EQ-M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210475
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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