510(k) · Cleared
ClearedClear Aligner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Royal Dental Lab · NXC Aligner, Sequential
Cleared on Jan 8, 2020 as substantially equivalent to K173784 (Smylio, Inc., 2018) after a 100-day review. Its family tree reaches back 1 generation to 2018. 2 later devices descend from it.
- Decided
- Jan 8, 2020
- Review
- 100 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K173784 (2018). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK173784 Smylic Invisible Clear AlignersSmylio, Inc. · 2018
- This deviceK192767 Clear AlignerRoyal Dental Lab · 2020
- Descendant · cites it directly · 1 of its ownK210373 Clear AlignersShenzhen Yinuo Dental Technology Co.Ltd · 2021
- Descendant · 2 generations on · 0 of its ownK222918 DentCare AlignersDentcare Dental Lab Pvt, Ltd. · 2022
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 |
|---|---|---|---|---|---|
| −1 | K173784 | Smylic Invisible Clear Aligners | Smylio, Inc. | 2018 | — |
| 0 (this device) | K192767 | Clear Aligner | Royal Dental Lab | 2020 | — |
| +1 | K210373 | Clear Aligners | Shenzhen Yinuo Dental Technology Co.Ltd | 2021 | — |
| +2 | K222918 | DentCare Aligners | Dentcare Dental Lab Pvt, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173784 | Smylic Invisible Clear AlignersSummary page 4…e NXC Review panel: Regulation Dental class: Class I1 (4) Primary Predicate Sponsor Smylio, Inc. Device Name and Model Smylio Invisible Clear Aligners 510(k) Number K173784 Product Code NXC Regulation Number 21 CFR 872.5470 Regulation Class II (5) Reference device This reference device - 3Shape Ort… | 2018 |
| † | K152086 | 3Shape Ortho System | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210373 | Clear Aligners | 2021 | 1 |
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 NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 permanent teeth through orthodontic treatment of misalignment and malocclusion.
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/K192767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192767: Clear Aligner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192767
Report an extraction error
Are you the manufacturer?
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