510(k) · Cleared
ClearedClear Image Aligners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialty Appliance Works, Inc. · NXC Aligner, Sequential
Cleared on Jan 3, 2019 as substantially equivalent to K173785 (Derby Dental Laboratory, 2018) after an 8-day review. Its family tree reaches back 6 generations to 1978. 1 later device descends from it.
- Decided
- Jan 3, 2019
- Review
- 8 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K780619 (1978). 8 ancestors in all. 1 later device descends 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 backK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
- 3 generations backK082556 ClearcorrectClearcorrect, Inc. · 2009
- 2 generations backK113618 Clearcorrect SystemClearcorrect, Inc. · 2012
- 1 generation backK173785 Custom Clear Aligner SystemDerby Dental Laboratory · 2018
- This deviceK183643 Clear Image AlignersSpecialty Appliance Works, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK192470 DenMat Orthodontic AlignersDenmat Holdings, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K192470DenMat Orthodontic AlignersDenmat Holdings, LLC · 2019 · cites it directly0descendants
View 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 | K071970 | Clear Image Aligner | Specialty Appliance Works, Inc. | 2007 | — |
| −3 | K082556 | Clearcorrect | Clearcorrect, Inc. | 2009 | — |
| −2 | K113618 | Clearcorrect System | Clearcorrect, Inc. | 2012 | — |
| −1 | K173785 | Custom Clear Aligner System | Derby Dental Laboratory | 2018 | — |
| 0 (this device) | K183643 | Clear Image Aligners | Specialty Appliance Works, Inc. | 2019 | — |
| +1 | K192470 | DenMat Orthodontic Aligners | Denmat Holdings, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K173785 | Custom Clear Aligner SystemSummary page 4…Sequential Aligners Classification: 21 CFR 872.5470: Orthodontic plastic bracket; Class II Product Code: NXC Predicate Device: K173785, Derby Dental Laboratory Custom Clear Aligner System Intended Use / Indications: The Clear Image A… | 2018 |
| † | K171634 | Ortho System | 2018 |
| † | K152086 | 3Shape Ortho System | 2016 |
| † | K062828 | Mouthguard and Aligner Materials | 2006 |
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 |
|---|---|---|---|
| K192470 | DenMat Orthodontic Aligners | 2019 | 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 41 years and passes through 5 companies; a new generation was cleared every 6.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K192470 (Denmat Holdings, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K173785.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Image Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion,
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/K183643 · printed Nov 3, 2026
Cite this page
510(k) Report. “K183643: Clear Image Aligners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K183643
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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