510(k) · Cleared
ClearedAPX21
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techdent Technologies, Ltd. · LQY Locator, Root Apex
Cleared on Mar 6, 2008 as substantially equivalent to K921979 (J. Morita USA, Inc., 1993) after a 114-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Mar 6, 2008
- Review
- 114 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921979 (1993). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K103123Apex Pointer+; Measruing Cable, Hook, Lip Clip, Touch Probe (Accessories)Micro-Mega Societe Anonyme · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| 0 (this device) | K073185 | APX21 | Techdent Technologies, Ltd. | 2008 | — |
| +1 | K103123 | Apex Pointer+; Measruing Cable, Hook, Lip Clip, Touch Probe (Accessories) | Micro-Mega Societe Anonyme | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K921979 | Root ZXSummary page 1…ex Review Panel: Dental Product Code: LQY Device Class: Unclassified (Pre-Amendment) Devices to which substantiall equivalence is claimed: K921979 ROOT ZX J. MORITA USA Inc, Device Description 5 The APX21 is an electronic apparat… | 1993 |
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 |
|---|---|---|---|
| K103123 | Apex Pointer+; Measruing Cable, Hook, Lip Clip, Touch Probe (Accessories) | 2011 | 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?
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The APX21 is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073185 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073185: APX21.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073185
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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