510(k) · Cleared
ClearedAlign System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Align Technology · NXC Aligner, Sequential
Cleared on Sep 8, 1998 as substantially equivalent to K780619 (Tp Laboratories, Inc., 1978) after a 166-day review. Its family tree reaches back 1 generation to 1978. 135 later devices descend from it.
- Decided
- Sep 8, 1998
- Review
- 166 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K780619 (1978). 135 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- This deviceK981095 Align SystemAlign Technology · 1998
- Descendant · cites it directly · 82 of its ownK081960 Invisalign SystemAlign Technology · 2008
- Descendant · cites it directly · 67 of its ownK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
- Descendant · cites it directly · 64 of its ownK082556 ClearcorrectClearcorrect, Inc. · 2009
- Descendant · 2 generations on · 60 of its ownK113618 Clearcorrect SystemClearcorrect, Inc. · 2012
- Descendant · 2 generations on · 41 of its ownK143630 Invisalign SystemAlign Technology, Inc. · 2015
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 135 · See all- K081960Invisalign SystemAlign Technology · 2008 · cites it directly82descendants
- K071970Clear Image AlignerSpecialty Appliance Works, Inc. · 2007 · cites it directly67descendants
- K082556ClearcorrectClearcorrect, Inc. · 2009 · cites it directly64descendants
- K113618Clearcorrect SystemClearcorrect, Inc. · 2012 · 2 generations on60descendants
- K143630Invisalign SystemAlign Technology, Inc. · 2015 · 2 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| 0 (this device) | K981095 | Align System | Align Technology | 1998 | — |
| +1 | K081960 | Invisalign System | Align Technology | 2008 | — |
| +1 | K071970 | Clear Image Aligner | Specialty Appliance Works, Inc. | 2007 | — |
| +1 | K082556 | Clearcorrect | Clearcorrect, Inc. | 2009 | — |
| +2 | K113618 | Clearcorrect System | Clearcorrect, Inc. | 2012 | — |
| +2 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 10 | 0 |
| 2019 | 15 | 0 |
| 2020 | 15 | 0 |
| 2021 | 18 | 0 |
| 2022 | 16 | 0 |
| 2023 | 13 | 0 |
| 2024 | 14 | 0 |
| 2025 | 10 | 0 |
| 2026 | 5 | 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? (3)
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 |
|---|---|---|---|
| * | K780619 | Preformed Tooth PositionerSummary page 4…r (872.5525) IDENTIFICATION OF PREDICATE DEVICE Device S510(k) No. Great Lakes Orthodontics Preformed Tooth Positioner Class I Exempt TP Orthodontics Tooth Positioner K780619 Ortho-Tain Tooth Positioner Class I Exempt Date Cleared Not Applicable June 28, 1978 Not Applicable 195 ~ A“… | 1978 |
| * | — | Great Lakes Orthodontics Preformed Tooth Positioner Named without a submission number | |
| * | — | Ortho-Tain Tooth Positioner Named without a submission number |
What descends from it? (135)
See all 1359 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081960 | Invisalign System | 2008 | 82 |
| K071970 | Clear Image Aligner | 2007 | 67 |
| K082556 | Clearcorrect | 2009 | 64 |
| K073121 | Nubrace Invisible Removable Orthodontics | 2009 | 7 |
| K123514 | Clearpath Aligner | 2013 | 6 |
| K062828 | Mouthguard and Aligner Materials | 2006 | 6 |
| K183229 | Argen Clear Aligner | 2019 | 3 |
| K123925 | MTM Clear Aligner in-Office | 2013 | 2 |
| K080246 | Composite Aligner Button | 2008 | 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?
- Its one ancestor has no recall.
- Of its descendants, K081960 (Align Technology, 2008) has gone furthest, with 82 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.
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 Align System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Align System 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/K981095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981095: Align System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981095
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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