510(k) · Cleared
ClearedByte Aligner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straight Smile, LLC · NXC Aligner, Sequential
Cleared on Feb 19, 2019 as substantially equivalent to K113618 (Clearcorrect, Inc., 2012) after a 376-day review. Its family tree reaches back 5 generations to 1978. 5 later devices descend from it.
- Decided
- Feb 19, 2019
- Review
- 376 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K780619 (1978). 7 ancestors in all. 5 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 deviceK180346 Byte Aligner SystemStraight Smile, LLC · 2019
- Descendant · cites it directly · 1 of its ownK203624 Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK230199 Byte Aligner SystemDentsply Sirona, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK223454 Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK212961 SmilersBiotech Dental Smilers, Sas · 2021
- Descendant · cites it directly · 0 of its ownK191774 SmileAlign Orthodontic Aligner System3D Global Biotech, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K203624Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd. · 2022 · cites it directly1descendant
- K230199Byte Aligner SystemDentsply Sirona, Inc. · 2023 · cites it directly0descendants
- K223454Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd. · 2023 · 2 generations on0descendants
- K212961SmilersBiotech Dental Smilers, Sas · 2021 · cites it directly0descendants
- K191774SmileAlign Orthodontic Aligner System3D Global Biotech, Inc. · 2019 · cites it directly0descendants
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) | K180346 | Byte Aligner System | Straight Smile, LLC | 2019 | — |
| +1 | K203624 | Custom-made Invisible Aligners | Zhejiang Yinchili Medical Technology Co., Ltd. | 2022 | — |
| +1 | K230199 | Byte Aligner System | Dentsply Sirona, Inc. | 2023 | 1 |
| +2 | K223454 | Custom-made Invisible Aligners | Zhejiang Yinchili Medical Technology Co., Ltd. | 2023 | — |
| +1 | K212961 | Smilers | Biotech Dental Smilers, Sas | 2021 | — |
| +1 | K191774 | SmileAlign Orthodontic Aligner System | 3D Global Biotech, Inc. | 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 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K113618 | Clearcorrect SystemSummary page 4…e Device Manufacturer: ClearCorrect, Inc Predicate Device Common Name: Sequential Aligners Predicate Device Premarket Notification # K113618 Predicate Device Classification: 21 CFR 872.5470 Predicate Device Classification & Class 2, Prod… | 2012 |
| † | K172765 | Smart Moves Complete | 2018 |
What descends from it? (5)
4 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 41 years and passes through 5 companies; a new generation was cleared every 6.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K203624 (Zhejiang Yinchili Medical Technology Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 15 other devices also cite its predicate K113618.
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 Byte Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Byte Aligner System positions teeth by way of continuous gentle force.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180346: Byte Aligner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180346
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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