510(k) · Cleared
ClearedClear Moves Aligners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Space Maintainers Laboratories (Sml) · NXC Aligner, Sequential
Cleared on Apr 4, 2024 as substantially equivalent to K223141 (Str8 Oral Care, 2023) after a 90-day review. Its family tree reaches back 8 generations to 1978.
- Decided
- Apr 4, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K780619 (1978). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 7 generations backK981095 Align SystemAlign Technology · 1998
- 6 generations backK081960 Invisalign SystemAlign Technology · 2008
- 5 generations backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- 4 generations backK203737 Spark Clear Aligner SystemOrmco Corporation · 2021
- 3 generations backK212660 Smylio Invisible Clear AlignersSmylio, Inc. · 2021
- 2 generations backK211510 uLab Systems Dental Aligner KitUlab Systems, Inc. · 2022
- 1 generation backK223141 STR8 Clear AlignerStr8 Oral Care · 2023
- This deviceK240038 Clear Moves AlignersSpace Maintainers Laboratories (Sml) · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −7 | K981095 | Align System | Align Technology | 1998 | — |
| −6 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −5 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| −4 | K203737 | Spark Clear Aligner System | Ormco Corporation | 2021 | — |
| −3 | K212660 | Smylio Invisible Clear Aligners | Smylio, Inc. | 2021 | — |
| −2 | K211510 | uLab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2022 | — |
| −1 | K223141 | STR8 Clear Aligner | Str8 Oral Care | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K223141 | STR8 Clear AlignerSummary page 5…Classification Panel: Dental Products Panel Reviewing Branch Dental Devices Branch PRIDICATE DEVICE Primary Predicate Device: K223141 STR8 Clear Aligners STR8 Oral Care DEVICE DESCRIPTION The Clear Moves Aligner is a series of clear, light wei… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 46 years and passes through 8 companies; a new generation was cleared every 5.3 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Clear Moves Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Clear Moves Aligners position teeth by way of continuous gentle force.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240038: Clear Moves Aligners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240038
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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