510(k) · Cleared
ClearedDenta Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · LQY Locator, Root Apex
Cleared on Dec 20, 2002 as substantially equivalent to K970339 (J. Morita USA, Inc., 1997) after a 171-day review. Its family tree reaches back 1 generation to 1997. 16 later devices descend from it.
- Decided
- Dec 20, 2002
- Review
- 171 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970339 (1997). 16 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- This deviceK022147 Denta PortJ. Morita USA, Inc. · 2002
- Descendant · cites it directly · 15 of its ownK031204 Dentaport ZXJ. Morita USA, Inc. · 2003
- Descendant · 2 generations on · 6 of its ownK071190 Root ZX IIJ. Morita USA, Inc. · 2007
- Descendant · cites it directly · 6 of its ownK042822 TCM Endo V, Model 1534Nouvag AG · 2004
- Descendant · 2 generations on · 2 of its ownK150750 Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH · 2015
- Descendant · 3 generations on · 2 of its ownK090925 Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K031204Dentaport ZXJ. Morita USA, Inc. · 2003 · cites it directly15descendants
- K071190Root ZX IIJ. Morita USA, Inc. · 2007 · 2 generations on6descendants
- K042822TCM Endo V, Model 1534Nouvag AG · 2004 · cites it directly6descendants
- K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH · 2015 · 2 generations on2descendants
- K090925Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| 0 (this device) | K022147 | Denta Port | J. Morita USA, Inc. | 2002 | — |
| +1 | K031204 | Dentaport ZX | J. Morita USA, Inc. | 2003 | — |
| +2 | K071190 | Root ZX II | J. Morita USA, Inc. | 2007 | — |
| +1 | K042822 | TCM Endo V, Model 1534 | Nouvag AG | 2004 | — |
| +2 | K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | 2015 | — |
| +3 | K090925 | Multiple (Apex Locator), Model RCM-7 | J. Morita USA, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 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 LQY? 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 LQY device
- #1 K252224 Apex Locator (FindPex)score 12.0 · 4 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970339 | Tri Auto ZXSummary page 3…able battery is used for power supply. 2 The DENTA PORT is substantially equivalent to the Tri Auto ZX (K#970339) because both devices have similar general intended uses, technological characteristics, and operating principles. The principal… | 1997 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LQY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LQY
164in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LQY
No recall names LQY since 2007.
Adverse event reports per year · LQY
51in 2025
MAUDE reports naming product code LQY, 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 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 15 |
| 2010 | 3 | 164 | 0 | 22 |
| 2011 | 2 | — | 0 | 140 |
| 2012 | 2 | — | 0 | 59 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 1 | — | 0 | 128 |
| 2017 | 0 | — | 0 | 133 |
| 2018 | 2 | — | 0 | 154 |
| 2019 | 1 | — | 0 | 163 |
| 2020 | 0 | — | 0 | 139 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 56 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 51 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DENTA PORT is a dental root canal measurement and treatment device that
can measure the length of the root canal and enlarge the canal while monitoring the
position of the file tip inside the canal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022147: Denta Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022147
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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