510(k) · Cleared
ClearedZSmile System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dror Orthodesign, Ltd. · NXC Aligner, Sequential
Cleared on Feb 3, 2026 as substantially equivalent to K192069 (Dror Orthodesign, 2020) after a 127-day review. Its family tree reaches back 6 generations to 1978.
- Decided
- Feb 3, 2026
- Review
- 127 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K780619 (1978). No later device cites it as a predicate yet.
- Root · 6 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 5 generations backK981095 Align SystemAlign Technology · 1998
- 4 generations backK081960 Invisalign SystemAlign Technology · 2008
- 3 generations backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- 2 generations backK181739 Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc. · 2018
- 1 generation backK192069 Aerodentis SystemDror Orthodesign · 2020
- This deviceK253282 ZSmile SystemDror Orthodesign, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −5 | K981095 | Align System | Align Technology | 1998 | — |
| −4 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −3 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| −2 | K181739 | Invisalign System with Mandibular Advancement Feature | Align Technology, Inc. | 2018 | — |
| −1 | K192069 | Aerodentis System | Dror Orthodesign | 2020 | — |
| 0 (this device) | K253282 | ZSmile System | Dror Orthodesign, Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K192069 | Aerodentis SystemSummary page 5…ass II, per 21 CFR 872.5470 Product Code: NXC. Classification Panel: Dental III. PREDICATE DEVICE Name of Device: ZSmile System (former Aerodentis System) cleared under K192069 Common or Usual Name: ZSmile System Classification Name: Orthodontic plastic bracket Regulatory Class: Class II, per 21 CFR 872.5… | 2020 |
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 48 years and passes through 5 companies; a new generation was cleared every 6.9 years on median.
- None of the 6 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. 2026, 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 ZSmile System is indicated for use in movement and alignment of teeth during orthodontic treatment of malocclusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253282 · printed Nov 3, 2026
Cite this page
510(k) Report. “K253282: ZSmile System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K253282
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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