510(k) · Cleared
ClearedClear Aligners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Yinuo Dental Technology Co.Ltd · NXC Aligner, Sequential
Cleared on Aug 27, 2021 as substantially equivalent to K192767 (Royal Dental Lab, 2020) after a 200-day review. Its family tree reaches back 2 generations to 2018. 1 later device descends from it.
- Decided
- Aug 27, 2021
- Review
- 200 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K173784 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK173784 Smylic Invisible Clear AlignersSmylio, Inc. · 2018
- 1 generation backK192767 Clear AlignerRoyal Dental Lab · 2020
- This deviceK210373 Clear AlignersShenzhen Yinuo Dental Technology Co.Ltd · 2021
- Descendant · cites it directly · 0 of its ownK222918 DentCare AlignersDentcare Dental Lab Pvt, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222918DentCare AlignersDentcare Dental Lab Pvt, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K173784 | Smylic Invisible Clear Aligners | Smylio, Inc. | 2018 | — |
| −1 | K192767 | Clear Aligner | Royal Dental Lab | 2020 | — |
| 0 (this device) | K210373 | Clear Aligners | Shenzhen Yinuo Dental Technology Co.Ltd | 2021 | — |
| +1 | K222918 | DentCare Aligners | Dentcare Dental Lab Pvt, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 NXC? 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 NXC device
- #1 K220287 Invisalign Systemscore 20.3 · 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222918 | DentCare Aligners | 2022 | 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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K222918 (Dentcare Dental Lab Pvt, Ltd., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NXC
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NXC
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NXC
4,523in 2025
MAUDE reports naming product code NXC, 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 | 1 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 59 |
| 2012 | 2 | — | 0 | 24 |
| 2013 | 4 | 124 | 0 | 28 |
| 2014 | 0 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 43 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 3 | 85 | 0 | 47 |
| 2018 | 11 | 116 | 0 | 67 |
| 2019 | 16 | 182 | 0 | 127 |
| 2020 | 16 | 230 | 0 | 175 |
| 2021 | 20 | 97 | 0 | 929 |
| 2022 | 19 | 137 | 0 | 605 |
| 2023 | 13 | 152 | 0 | 433 |
| 2024 | 14 | 105 | 2 | 8,991 |
| 2025 | 11 | 61 | 0 | 4,523 |
| 2026 | 5 | 127 | 0 | — |
What is it indicated for?
This device is indicated for use in the alignment of all permanent dentition through orthodontic treatment of misalignment and malocclusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210373: Clear Aligners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210373
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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