510(k) · Cleared
ClearedSpark Clear Aligner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ormco Corporation · NXC Aligner, Sequential
Cleared on Mar 22, 2021 as substantially equivalent to K143630 (Align Technology, Inc., 2015) after a 90-day review. Its family tree reaches back 4 generations to 1978. 10 later devices descend from it.
- Decided
- Mar 22, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K780619 (1978). 10 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 3 generations backK981095 Align SystemAlign Technology · 1998
- 2 generations backK081960 Invisalign SystemAlign Technology · 2008
- 1 generation backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- This deviceK203737 Spark Clear Aligner SystemOrmco Corporation · 2021
- 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 · 1 of its ownK240501 Spark™ Clear Aligner SystemOrmco Corporation · 2024
- 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 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K212660Smylio Invisible Clear AlignersSmylio, Inc. · 2021 · cites it directly7descendants
- K211510uLab Systems Dental Aligner KitUlab Systems, Inc. · 2022 · 2 generations on2descendants
- K240501Spark™ Clear Aligner SystemOrmco Corporation · 2024 · cites it directly1descendant
- 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 |
|---|---|---|---|---|---|
| −4 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −3 | K981095 | Align System | Align Technology | 1998 | — |
| −2 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −1 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| 0 (this device) | K203737 | Spark Clear Aligner System | Ormco Corporation | 2021 | — |
| +1 | K212660 | Smylio Invisible Clear Aligners | Smylio, Inc. | 2021 | — |
| +2 | K211510 | uLab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2022 | — |
| +1 | K240501 | Spark™ Clear Aligner System | Ormco Corporation | 2024 | — |
| +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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K143630 | Invisalign SystemSummary page 4…x Device Class: II x Product Code: NXC, PNN 3. Predicate Device (Primary): x Proprietary Name: Invisalign System (K143630) x Manufacturer: Align Technology, Inc. x Common Name: Aligner, Sequential… | 2015 |
| † | K182826 | Ormco Spark Aligner System | 2018 |
| † | K192244 | Arcad SmileStudio and Aligner System | 2020 |
What descends from it? (10)
2 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 4 companies; a new generation was cleared every 10.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K212660 (Smylio, Inc., 2021) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K143630.
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?
Spark™ Clear Aligner System: The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion. Spark™ Software System: The Spark™ Software System is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner…
Read the full statement (168 words)
Spark™ Clear Aligner System:
The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Spark™ Software System:
The Spark™ Software System is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays, retainers or bracket bonding templatesor based on 3D models of the patient’s dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the Spark™ Clear Aligner System and Spark™ Software System requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.
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/K203737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203737: Spark Clear Aligner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203737
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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