510(k) · Cleared
ClearedSmylio 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 Sep 22, 2021 as substantially equivalent to K203737 (Ormco Corporation, 2021) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 1978. 7 later devices descend from it.
- Decided
- Sep 22, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K780619 (1978). 6 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 4 generations backK981095 Align SystemAlign Technology · 1998
- 3 generations backK081960 Invisalign SystemAlign Technology · 2008
- 2 generations backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- 1 generation backK203737 Spark Clear Aligner SystemOrmco Corporation · 2021
- This deviceK212660 Smylio Invisible Clear AlignersSmylio, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK211510 uLab Systems Dental Aligner KitUlab Systems, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK233356 Illusion Aligner Pro: Illusion Aligner FLXLaxmi Dental Export Pvt., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK223141 STR8 Clear AlignerStr8 Oral Care · 2023
- Descendant · cites it directly · 1 of its ownK220726 K ClearKline Europe GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK260527 FACE4D AlignerAvinent Implant System S.L.U. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K211510uLab Systems Dental Aligner KitUlab Systems, Inc. · 2022 · cites it directly2descendants
- K233356Illusion Aligner Pro: Illusion Aligner FLXLaxmi Dental Export Pvt., Ltd. · 2024 · cites it directly1descendant
- K223141STR8 Clear AlignerStr8 Oral Care · 2023 · 2 generations on1descendant
- K220726K ClearKline Europe GmbH · 2022 · cites it directly1descendant
- K260527FACE4D AlignerAvinent Implant System S.L.U. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −4 | K981095 | Align System | Align Technology | 1998 | — |
| −3 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −2 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| −1 | K203737 | Spark Clear Aligner System | Ormco Corporation | 2021 | — |
| 0 (this device) | K212660 | Smylio Invisible Clear Aligners | Smylio, Inc. | 2021 | — |
| +1 | K211510 | uLab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2022 | — |
| +1 | K233356 | Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. | 2024 | — |
| +2 | K223141 | STR8 Clear Aligner | Str8 Oral Care | 2023 | — |
| +1 | K220726 | K Clear | Kline Europe GmbH | 2022 | — |
| +2 | K260527 | FACE4D Aligner | Avinent Implant System S.L.U. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K203737 | Spark Clear Aligner SystemSummary page 4…August 2%, 2021 Smylio Invisible Clear Aligners Orthodontic plastic bracket. NXC — Orthodontic plastic bracket. Class Il, 21 CFR 872.5470 Spark Clear Aligner System (K203737) Invisalign System (K143630) Smylio Invisible Clear Aligners (K173784) Device Description: The Smylio Invisible Clear Aligner… | 2021 |
| * | K173784 | Smylic Invisible Clear AlignersSummary page 4…acket. NXC — Orthodontic plastic bracket. Class Il, 21 CFR 872.5470 Spark Clear Aligner System (K203737) Invisalign System (K143630) Smylio Invisible Clear Aligners (K173784) Device Description: The Smylio Invisible Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to f… | 2018 |
| † | K143630 | Invisalign System | 2015 |
What descends from it? (7)
3 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 43 years and passes through 5 companies; a new generation was cleared every 6.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K211510 (Ulab Systems, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K203737.
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?
The Smylio Invisible Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of 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/K212660 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212660: Smylio Invisible Clear Aligners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212660
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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