510(k) · Cleared
ClearedSmylic Invisible Clear Aligners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smylio, Inc. · NXC Aligner, Sequential
Cleared on Aug 23, 2018 after a 253-day review. The FDA summary names no predicate by number. 16 later devices descend from it.
- Decided
- Aug 23, 2018
- Review
- 253 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 5 citing it directly.
- This deviceK173784 Smylic Invisible Clear AlignersSmylio, Inc. · 2018
- Descendant · cites it directly · 7 of its ownK212660 Smylio Invisible Clear AlignersSmylio, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK211510 uLab Systems Dental Aligner KitUlab Systems, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK192767 Clear AlignerRoyal Dental Lab · 2020
- Descendant · 2 generations on · 1 of its ownK233356 Illusion Aligner Pro: Illusion Aligner FLXLaxmi Dental Export Pvt., Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK223141 STR8 Clear AlignerStr8 Oral Care · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K212660Smylio Invisible Clear AlignersSmylio, Inc. · 2021 · cites it directly7descendants
- K211510uLab Systems Dental Aligner KitUlab Systems, Inc. · 2022 · 2 generations on2descendants
- K192767Clear AlignerRoyal Dental Lab · 2020 · cites it directly2descendants
- K233356Illusion Aligner Pro: Illusion Aligner FLXLaxmi Dental Export Pvt., Ltd. · 2024 · 2 generations on1descendant
- K223141STR8 Clear AlignerStr8 Oral Care · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K173784 | Smylic Invisible Clear Aligners | Smylio, Inc. | 2018 | — |
| +1 | K212660 | Smylio Invisible Clear Aligners | Smylio, Inc. | 2021 | — |
| +2 | K211510 | uLab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2022 | — |
| +1 | K192767 | Clear Aligner | Royal Dental Lab | 2020 | — |
| +2 | K233356 | Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. | 2024 | — |
| +3 | K223141 | STR8 Clear Aligner | Str8 Oral Care | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (16)
See all 165 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?
- Of its descendants, K212660 (Smylio, Inc., 2021) has gone furthest, with 7 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. 2018, 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 | — |
https://510kreport.com/device/K173784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173784: Smylic Invisible 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/K173784
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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