510(k) · Cleared
ClearedMultiple (Apex Locator), Model RCM-7
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 Nov 23, 2009 as substantially equivalent to K921979 (J. Morita USA, Inc., 1993) and 2 other predicates after a 235-day review. Its family tree reaches back 6 generations to 1995. 2 later devices descend from it.
- Decided
- Nov 23, 2009
- Review
- 235 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K951425 (1995). 13 ancestors in all, the oldest K921979 (1993). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK090925 Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK151274 Dr's FinderGood Doctors Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK171867 Dr’s Finder NEOGood Doctors Co., Ltd. · 2018
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 |
|---|---|---|---|---|---|
| −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) | K090925 | Multiple (Apex Locator), Model RCM-7 | J. Morita USA, Inc. | 2009 | — |
| +1 | K151274 | Dr's Finder | Good Doctors Co., Ltd. | 2016 | — |
| +1 | K171867 | Dr’s Finder NEO | Good Doctors Co., Ltd. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K921979 | Root ZXSummary page 2…e RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal. SUBSTANTIAL EQUIVALENCE The RCM-7 is substantially equivalent to Root ZX (K921979 / K953867) and the Canal Measurement Module of DP-ZX-VL (K071190). 1) Predicate device I: Root ZX (K921979 / K953867) The RCM-7… | 1993 |
| * | K953867 | Root Canal Length Measuring DeviceSummary page 2…a dental device, Apex Locator. It can be used to detect the apex of root canal. SUBSTANTIAL EQUIVALENCE The RCM-7 is substantially equivalent to Root ZX (K921979 / K953867) and the Canal Measurement Module of DP-ZX-VL (K071190). 1) Predicate device I: Root ZX (K921979 / K953867) The RCM-7 is substa… | 1995 |
| * | K071190 | Root ZX IISummary page 2…t the apex of root canal. SUBSTANTIAL EQUIVALENCE The RCM-7 is substantially equivalent to Root ZX (K921979 / K953867) and the Canal Measurement Module of DP-ZX-VL (K071190). 1) Predicate device I: Root ZX (K921979 / K953867) The RCM-7 is substantially equivalent to Root ZX from J.MORITA MFG.CORP. T… | 2007 |
What descends from it? (2)
2 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K151274 (Good Doctors Co., Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K921979.
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
RCM-7 is a dental device, Apex Locator.
It can be used to detect the apex of root canal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090925: Multiple (Apex Locator), Model RCM-7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090925
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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