510(k) · Cleared
ClearedFS Aligner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allesee Orthodontic Appliances · NXC Aligner, Sequential
Cleared on Aug 27, 2010 after a 256-day review. The FDA summary names its predicate without a number. 61 later devices descend from it.
- Decided
- Aug 27, 2010
- Review
- 256 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 0
61 later devices descend from it, 1 citing it directly.
- This deviceK093821 FS AlignerAllesee Orthodontic Appliances · 2010
- 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 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K093821 | FS Aligner | Allesee Orthodontic Appliances | 2010 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 7 | 0 |
| 2019 | 9 | 0 |
| 2020 | 9 | 0 |
| 2021 | 7 | 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 |
|---|---|---|---|
| * | — | Align Technology, Invisalign Named without a submission number | |
| * | — | Red, White & Blue, Allesee Orthodontic Appliances Named without a submission number |
What descends from it? (61)
See all 611 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113618 | Clearcorrect System | 2012 | 60 |
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?
- Of its descendants, K113618 (Clearcorrect, Inc., 2012) has gone furthest, with 60 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. 2010, 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 FS Aligner System is intended for minor anterior tooth movement in patients with permanent dentition (second molars). The FS Aligner System positions teeth by way of continuous gentle force.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093821: FS Aligner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093821
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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