510(k) · Cleared
CleareduLab Systems Dental Aligner Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulab Systems, Inc. · NXC Aligner, Sequential
Cleared on Feb 24, 2022 as substantially equivalent to K212660 (Smylio, Inc., 2021) after a 286-day review. Its family tree reaches back 6 generations to 1978. 2 later devices descend from it.
- Decided
- Feb 24, 2022
- Review
- 286 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K780619 (1978). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 5 generations backK981095 Align SystemAlign Technology · 1998
- 4 generations backK081960 Invisalign SystemAlign Technology · 2008
- 3 generations backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- 2 generations backK203737 Spark Clear Aligner SystemOrmco Corporation · 2021
- 1 generation backK212660 Smylio Invisible Clear AlignersSmylio, Inc. · 2021
- This deviceK211510 uLab Systems Dental Aligner KitUlab Systems, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK223141 STR8 Clear AlignerStr8 Oral Care · 2023
- Descendant · 2 generations on · 0 of its ownK240038 Clear Moves AlignersSpace Maintainers Laboratories (Sml) · 2024
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 |
|---|---|---|---|---|---|
| −6 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −5 | K981095 | Align System | Align Technology | 1998 | — |
| −4 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −3 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| −2 | K203737 | Spark Clear Aligner System | Ormco Corporation | 2021 | — |
| −1 | K212660 | Smylio Invisible Clear Aligners | Smylio, Inc. | 2021 | — |
| 0 (this device) | K211510 | uLab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2022 | — |
| +1 | K223141 | STR8 Clear Aligner | Str8 Oral Care | 2023 | — |
| +2 | K240038 | Clear Moves Aligners | Space Maintainers Laboratories (Sml) | 2024 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K212660 | Smylio Invisible Clear Aligners Cleared while this submission was under review Summary page 4…21CFR 872.5470 Device Class: II Product Code: NXC Primary Predicate Device: Smylio Invisible Clear Aligners (Smylio, Inc.), K212660 Reference Device: uLab Systems Dental Aligner Kit (uLab Systems, Inc.), K192596 Date Prepared: February 22, 2022 Device Descri… | 2021 |
| † | K192596 | ULab Systems Dental Aligner Kit | 2020 |
| † | K171295 | ULab Systems Treatment Planning Software | 2018 |
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 |
|---|---|---|---|
| K223141 | STR8 Clear Aligner | 2023 | 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?
- The line of descent spans 44 years and passes through 6 companies; a new generation was cleared every 6.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K223141 (Str8 Oral Care, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K212660.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 uLab Systems Dental Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211510: uLab Systems Dental Aligner Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211510
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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