510(k) · Cleared
ClearedCustom-made Invisible Aligners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Yinchili Medical Technology Co., Ltd. · NXC Aligner, Sequential
Cleared on Apr 17, 2023 as substantially equivalent to K203624 (Zhejiang Yinchili Medical Technology Co., Ltd., 2022) after a 152-day review. Its family tree reaches back 7 generations to 1978.
- Decided
- Apr 17, 2023
- Review
- 152 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K780619 (1978). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 6 generations backK981095 Align SystemAlign Technology · 1998
- 5 generations backK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
- 4 generations backK082556 ClearcorrectClearcorrect, Inc. · 2009
- 3 generations backK113618 Clearcorrect SystemClearcorrect, Inc. · 2012
- 2 generations backK180346 Byte Aligner SystemStraight Smile, LLC · 2019
- 1 generation backK203624 Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd. · 2022
- This deviceK223454 Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −6 | K981095 | Align System | Align Technology | 1998 | — |
| −5 | K071970 | Clear Image Aligner | Specialty Appliance Works, Inc. | 2007 | — |
| −4 | K082556 | Clearcorrect | Clearcorrect, Inc. | 2009 | — |
| −3 | K113618 | Clearcorrect System | Clearcorrect, Inc. | 2012 | — |
| −2 | K180346 | Byte Aligner System | Straight Smile, LLC | 2019 | — |
| −1 | K203624 | Custom-made Invisible Aligners | Zhejiang Yinchili Medical Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K223454 | Custom-made Invisible Aligners | Zhejiang Yinchili Medical Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K203624 | Custom-made Invisible AlignersSummary page 4…mation Classification Name: Aligner, Sequential Classification: Class II Product code: NXC Regulation Number: 21 CFR 872.5470 Review Panel: Dental C. Predicate device: K203624 (Primary Predicate) Custom-made Invisible Aligners Zhejiang Yinchili Medical Technology Co., Ltd. Reference device K181739 Invis… | 2022 |
| † | K181739 | Invisalign System with Mandibular Advancement Feature | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 45 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligners 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/K223454 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223454: Custom-made Invisible Aligners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223454
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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