510(k) · Cleared
ClearediSMILE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Diagnostix, Inc. · NXC Aligner, Sequential
Cleared on Dec 22, 2020 as substantially equivalent to K081960 (Align Technology, 2008) after a 260-day review. Its family tree reaches back 3 generations to 1978. 2 later devices descend from it.
- Decided
- Dec 22, 2020
- Review
- 260 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K780619 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 2 generations backK981095 Align SystemAlign Technology · 1998
- 1 generation backK081960 Invisalign SystemAlign Technology · 2008
- This deviceK200908 iSMILE3D Diagnostix, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK221537 Nightwear AlignersSmylio, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK222308 Al Smile AlignerNanjing Jiahe Dental Technology Co., Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView 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 | K081960 | Invisalign System | Align Technology | 2008 | — |
| 0 (this device) | K200908 | iSMILE | 3D Diagnostix, Inc. | 2020 | — |
| +1 | K221537 | Nightwear Aligners | Smylio, Inc. | 2023 | — |
| +1 | K222308 | Al Smile Aligner | Nanjing Jiahe Dental Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K081960 | Invisalign SystemSummary page 4…igners (21 CFR 892.5470) Regulatory Class: II Product Code: NXC Primary Predicate Devices lnvisalign System K081960 Align Technology, Inc. 3D Diagnostix Inc.… | 2008 |
What descends from it? (2)
2 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 42 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221537 (Smylio, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K081960.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
iSMILE is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200908: iSMILE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200908
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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