510(k) · Cleared
ClearedClearcorrect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearcorrect, Inc. · NXC Aligner, Sequential
Cleared on Feb 6, 2009 as substantially equivalent to K981095 (Align Technology, 1998) and 1 other predicate after a 155-day review. Its family tree reaches back 3 generations to 1978. 64 later devices descend from it.
- Decided
- Feb 6, 2009
- Review
- 155 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K780619 (1978). 4 ancestors in all. 64 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 2 generations backK981095 Align SystemAlign Technology · 1998
- 1 generation backK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
- This deviceK082556 ClearcorrectClearcorrect, Inc. · 2009
- Descendant · cites it directly · 60 of its ownK113618 Clearcorrect SystemClearcorrect, Inc. · 2012
- Descendant · 2 generations on · 15 of its ownK180241 Orthocaps TwinalignerOrtho Caps GmbH · 2018
- Descendant · 2 generations on · 13 of its ownK163689 3M Clear Tray Aligner3M Unitek Corporation · 2017
- Descendant · 3 generations on · 8 of its ownK192596 ULab Systems Dental Aligner KitUlab Systems, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK180346 Byte Aligner SystemStraight Smile, LLC · 2019
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K113618Clearcorrect SystemClearcorrect, Inc. · 2012 · cites it directly60descendants
- K180241Orthocaps TwinalignerOrtho Caps GmbH · 2018 · 2 generations on15descendants
- K1636893M Clear Tray Aligner3M Unitek Corporation · 2017 · 2 generations on13descendants
- K192596ULab Systems Dental Aligner KitUlab Systems, Inc. · 2020 · 3 generations on8descendants
- K180346Byte Aligner SystemStraight Smile, LLC · 2019 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −2 | K981095 | Align System | Align Technology | 1998 | — |
| −1 | K071970 | Clear Image Aligner | Specialty Appliance Works, Inc. | 2007 | — |
| 0 (this device) | K082556 | Clearcorrect | Clearcorrect, Inc. | 2009 | — |
| +1 | K113618 | Clearcorrect System | Clearcorrect, Inc. | 2012 | — |
| +2 | K180241 | Orthocaps Twinaligner | Ortho Caps GmbH | 2018 | — |
| +2 | K163689 | 3M Clear Tray Aligner | 3M Unitek Corporation | 2017 | — |
| +3 | K192596 | ULab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2020 | — |
| +2 | K180346 | Byte Aligner System | Straight Smile, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 9 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K981095 | Align SystemSummary page 1…Classification Sequential Aligner Name, Number & 852.5470 Product Code: NXC Predicate Devices: Invisaligh/Align System, Align Technology Inc., K981095 Clear Image Aligners, Specialty Appliances Works, Inc., K071970 Devic… | 1998 |
| * | K071970 | Clear Image AlignerSummary page 1…nvisaligh/Align System, Align Technology Inc., K981095 Clear Image Aligners, Specialty Appliances Works, Inc., K071970 Device Description Device Description: The.ClearCorrect device is fabricated of and Statement of clear, thin, thermoform… | 2007 |
What descends from it? (64)
See all 643 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 31 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K113618 (Clearcorrect, Inc., 2012) has gone furthest, with 60 descendants of its own.
- 8 other devices also cite its predicate K981095.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 CearCorrectSystem is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrectSystem positions teeth by way of continuous gentle force.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082556: Clearcorrect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082556
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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