510(k) · Cleared
Cleared3M Clear Tray Aligner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Unitek Corporation · NXC Aligner, Sequential
Cleared on Jan 27, 2017 as substantially equivalent to K081960 (Align Technology, 2008) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 1978. 13 later devices descend from it.
- Decided
- Jan 27, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K780619 (1978). 8 ancestors in all. 13 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 4 generations backK981095 Align SystemAlign Technology · 1998
- 3 generations backK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
- 2 generations backK082556 ClearcorrectClearcorrect, Inc. · 2009
- 1 generation backK113618 Clearcorrect SystemClearcorrect, Inc. · 2012
- This deviceK163689 3M Clear Tray Aligner3M Unitek Corporation · 2017
- Descendant · cites it directly · 4 of its ownK183159 3M Clarity Aligners3M Company · 2018
- Descendant · cites it directly · 4 of its ownK180107 Blue Sky Bio AlignerBlue Sky Bio, LLC · 2018
- Descendant · 2 generations on · 3 of its ownK192119 3M Clarity Aligners3M Company · 2019
- Descendant · 2 generations on · 2 of its ownK223355 Tera Harz ClearGraphy, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK211190 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity…3M Company, Unitek Orthodontic Products · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K1831593M Clarity Aligners3M Company · 2018 · cites it directly4descendants
- K180107Blue Sky Bio AlignerBlue Sky Bio, LLC · 2018 · cites it directly4descendants
- K1921193M Clarity Aligners3M Company · 2019 · 2 generations on3descendants
- K223355Tera Harz ClearGraphy, Inc. · 2022 · 2 generations on2descendants
- K2111903M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)3M Company, Unitek Orthodontic Products · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −4 | K981095 | Align System | Align Technology | 1998 | — |
| −3 | K071970 | Clear Image Aligner | Specialty Appliance Works, Inc. | 2007 | — |
| −2 | K082556 | Clearcorrect | Clearcorrect, Inc. | 2009 | — |
| −1 | K113618 | Clearcorrect System | Clearcorrect, Inc. | 2012 | — |
| 0 (this device) | K163689 | 3M Clear Tray Aligner | 3M Unitek Corporation | 2017 | — |
| +1 | K183159 | 3M Clarity Aligners | 3M Company | 2018 | — |
| +1 | K180107 | Blue Sky Bio Aligner | Blue Sky Bio, LLC | 2018 | — |
| +2 | K192119 | 3M Clarity Aligners | 3M Company | 2019 | — |
| +2 | K223355 | Tera Harz Clear | Graphy, Inc. | 2022 | — |
| +3 | K211190 | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) | 3M Company, Unitek Orthodontic Products | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K081960 | Invisalign SystemSummary page 5…molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force. Predicate Devices: Invisalign® System (K081960) [Primary Predicate] ClearCorrect System (K113618) [Predicate Device] Description of Device: The 3M Clear Tray Aligner System… | 2008 |
| * | K113618 | Clearcorrect SystemSummary page 5…ovements, it sequentially positions teeth by way of continuous gentle force. Predicate Devices: Invisalign® System (K081960) [Primary Predicate] ClearCorrect System (K113618) [Predicate Device] Description of Device: The 3M Clear Tray Aligner System is a series of clear plastic aligners that offer… | 2012 |
What descends from it? (13)
See all 134 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 39 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K183159 (3M Company, 2018) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K081960.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 3M™ Clear Tray Aligner system is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.
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/K163689 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163689: 3M Clear Tray Aligner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163689
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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