510(k) · Cleared
ClearedRoot ZX3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · EKZ Unit, Electrosurgical, And Accessories, Dental
Cleared on Aug 3, 2022 as substantially equivalent to K071190 (J. Morita USA, Inc., 2007) and 1 other predicate after a 278-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Aug 3, 2022
- Review
- 278 days
- Class
- Class II
- Product code
- EKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K951425 (1995). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK951425 Spectrum Curing Light Polymerization UnitDentsply Intl. · 1995
- 5 generations backK982318 Spectrum 800 Curing UnitDentsply Intl. · 1998
- 4 generations backK031615 Sled Curing Light SystemDentsply International · 2003
- 3 generations backK041372 Smartlite PS Pen-Style Led Curing LightDentsply International · 2004
- 2 generations backK063529 Pencure, Model VL-7J. Morita USA, Inc. · 2007
- 1 generation backK071190 Root ZX IIJ. Morita USA, Inc. · 2007
- This deviceK213477 Root ZX3J. Morita USA, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | 1995 | — |
| −5 | K982318 | Spectrum 800 Curing Unit | Dentsply Intl. | 1998 | — |
| −4 | K031615 | Sled Curing Light System | Dentsply International | 2003 | — |
| −3 | K041372 | Smartlite PS Pen-Style Led Curing Light | Dentsply International | 2004 | — |
| −2 | K063529 | Pencure, Model VL-7 | J. Morita USA, Inc. | 2007 | — |
| −1 | K071190 | Root ZX II | J. Morita USA, Inc. | 2007 | — |
| 0 (this device) | K213477 | Root ZX3 | J. Morita USA, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 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 EKZ? 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 |
|---|---|---|---|
| * | K071190 | Root ZX IISummary page 5…he predicates with regard to the FDA medical device regulations. Predicate for an apex locator: The primary predicate device is J. MORITA MFG. CORP.’s own ROOT ZX II (K#071190). Predicate for a dental electrosurgical unit: The predicate device for an electrosurgical unit is the Bonart Art-E1 Electrosurg… | 2007 |
| * | K020080 | Bonart Art-E1 Electrosurgery UnitSummary page 5….’s own ROOT ZX II (K#071190). Predicate for a dental electrosurgical unit: The predicate device for an electrosurgical unit is the Bonart Art-E1 Electrosurgery Unit (K#020080). The X O Odontosurge 4 (K#023672) is a reference device for the function of dental electrosurgical unit. Reference devices for… | 2002 |
| † | K023672 | X O Odontosurge 4 | 2003 |
| † | K090925 | Multiple (Apex Locator), Model RCM-7 | 2009 |
| † | K043497 | Air Solfy, Models as-4H, as-4H-O, as-4H-V, as-4H-OV, as-1,as-1-0,as-1-V, as-1-OV | 2005 |
| † | K170275 | Tri Auto ZX2 | 2017 |
| † | K063529 | Pencure, Model VL-7 | 2007 |
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 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 12 ancestors has a recall.
- 2 other devices also cite its predicate K071190.
How does its category compare?
All EKZ devicesEKZ Unit, Electrosurgical, And Accessories, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · EKZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · EKZ
Too few EKZ 510(k)s in any year since 2007 to give a median.
Recalls per year · EKZ
No recall names EKZ since 2007.
Adverse event reports per year · EKZ
6in 2018
MAUDE reports naming product code EKZ, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Root ZX3 device is a dental device with an apex locating function and an optional electrosurgical function and is composed of the aforementioned corresponding modules. The apex locating function of Root ZX3 device is used for root canal measurement and working length determination. The electrosurgical function is used for the following dental procedures: gingival incision and excision, gingivoplasty, gingivectomy, hemostasis, pulpotomy, pulpotomy as…
Read the full statement (113 words)
The Root ZX3 device is a dental device with an apex locating function and an optional electrosurgical function and is
composed of the aforementioned corresponding modules.
The apex locating function of Root ZX3 device is used for root canal measurement and working length determination.
The electrosurgical function is used for the following dental procedures: gingival incision and excision, gingivoplasty,
gingivectomy, hemostasis, pulpotomy, pulpotomy as an adjunct to root canal therapy, and excision of intraoral lesions. It
is also used for the ablation of pulp, dental filling material (e.g. gutta-percha) and tissue in/around root canals as an
adjunct to root canal therapy, after determining the tip position of the active electrode by apex location.
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/K213477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213477: Root ZX3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213477
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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