510(k) · Cleared
ClearedSTR8 Clear Aligner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Str8 Oral Care · NXC Aligner, Sequential
Cleared on Apr 24, 2023 as substantially equivalent to K211510 (Ulab Systems, Inc., 2022) after a 202-day review. Its family tree reaches back 7 generations to 1978. 1 later device descends from it.
- Decided
- Apr 24, 2023
- Review
- 202 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K780619 (1978). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 6 generations backK981095 Align SystemAlign Technology · 1998
- 5 generations backK081960 Invisalign SystemAlign Technology · 2008
- 4 generations backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- 3 generations backK203737 Spark Clear Aligner SystemOrmco Corporation · 2021
- 2 generations backK212660 Smylio Invisible Clear AlignersSmylio, Inc. · 2021
- 1 generation backK211510 uLab Systems Dental Aligner KitUlab Systems, Inc. · 2022
- This deviceK223141 STR8 Clear AlignerStr8 Oral Care · 2023
- Descendant · cites it directly · 0 of its ownK240038 Clear Moves AlignersSpace Maintainers Laboratories (Sml) · 2024
Most influential descendants
Showing 1 of 1 · See all- K240038Clear Moves AlignersSpace Maintainers Laboratories (Sml) · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −6 | K981095 | Align System | Align Technology | 1998 | — |
| −5 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −4 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| −3 | K203737 | Spark Clear Aligner System | Ormco Corporation | 2021 | — |
| −2 | K212660 | Smylio Invisible Clear Aligners | Smylio, Inc. | 2021 | — |
| −1 | K211510 | uLab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2022 | — |
| 0 (this device) | K223141 | STR8 Clear Aligner | Str8 Oral Care | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K211510 | uLab Systems Dental Aligner KitSummary page 4…NXC – Orthodontic plastic bracket Device Classification: Class II, 21 CFR 872.5470 Predicate Device: uLab Systems Dental Aligner (K211510) Classification Name: Aligner, Sequential Device Description: STR8 Clear Aligners are thermoforme… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240038 | Clear Moves Aligners | 2024 | 0 |
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 45 years and passes through 7 companies; a new generation was cleared every 5.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K240038 (Space Maintainers Laboratories (Sml), 2024) has gone furthest, with 0 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. 2023, 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 STR8 Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of
continuous gentle forces.
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/K223141 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223141: STR8 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/K223141
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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