510(k) · Cleared
ClearedOrmco Spark Aligner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Dental Specialties · NXC Aligner, Sequential
Cleared on Oct 11, 2018 as substantially equivalent to K143630 (Align Technology, Inc., 2015) after a 6-day review. Its family tree reaches back 4 generations to 1978. 6 later devices descend from it.
- Decided
- Oct 11, 2018
- Review
- 6 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K780619 (1978). 6 later devices descend from it, 5 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 deviceK182826 Ormco Spark Aligner SystemSybron Dental Specialties · 2018
- Descendant · cites it directly · 1 of its ownK210540 Ohlendorf Clear AlignerOhlendorf Appliance Laboratory · 2021
- Descendant · 2 generations on · 0 of its ownK241137 Clear Moves AlignerClear Moves Aligners · 2024
- Descendant · cites it directly · 0 of its ownK210652 6MS Invisible AlignerSms Opco, LLC · 2021
- Descendant · cites it directly · 0 of its ownK203339 NEOLab Clear AlignersNew England Ortho Lab, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK202685 Eon AlignerEon Dental Jordan, LLC · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K210540Ohlendorf Clear AlignerOhlendorf Appliance Laboratory · 2021 · cites it directly1descendant
- K241137Clear Moves AlignerClear Moves Aligners · 2024 · 2 generations on0descendants
- K2106526MS Invisible AlignerSms Opco, LLC · 2021 · cites it directly0descendants
- K203339NEOLab Clear AlignersNew England Ortho Lab, Inc. · 2021 · cites it directly0descendants
- K202685Eon AlignerEon Dental Jordan, LLC · 2020 · cites it directly0descendants
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) | K182826 | Ormco Spark Aligner System | Sybron Dental Specialties | 2018 | — |
| +1 | K210540 | Ohlendorf Clear Aligner | Ohlendorf Appliance Laboratory | 2021 | — |
| +2 | K241137 | Clear Moves Aligner | Clear Moves Aligners | 2024 | — |
| +1 | K210652 | 6MS Invisible Aligner | Sms Opco, LLC | 2021 | — |
| +1 | K203339 | NEOLab Clear Aligners | New England Ortho Lab, Inc. | 2021 | — |
| +1 | K202685 | Eon Aligner | Eon Dental Jordan, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 3 | 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 |
|---|---|---|---|
| * | K143630 | Invisalign SystemSummary page 4…Aligner System is substantially equivalent (as defined in 21 U.S.C. § 360c(i)) for all regulatory purposes to the legally marketed device Invisalign System K143630 cleared on November 18, 2015, product code NXC, by Align Technology. 4. Description of Device: The Ormco™… | 2015 |
| † | K113618 | Clearcorrect System | 2012 |
What descends from it? (6)
5 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 40 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, K210540 (Ohlendorf Appliance Laboratory, 2021) has gone furthest, with 1 descendant 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. 2018, 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 Ormco™ Spark™ Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The Ormco™ Spark™ Aligner System positions teeth by way of continuous gentle force.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182826: Ormco Spark 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/K182826
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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