510(k) · Cleared
ClearedSmileSeries
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ordont Orthodontic Laboratories, Inc. · NXC Aligner, Sequential
Cleared on Jul 14, 2022 as substantially equivalent to K202857 (Clearpath Orthodontics, Ltd., 2021) after a 91-day review. Its family tree reaches back 6 generations to 1978. 1 later device descends from it.
- Decided
- Jul 14, 2022
- Review
- 91 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K780619 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 5 generations backK981095 Align SystemAlign Technology · 1998
- 4 generations backK073121 Nubrace Invisible Removable OrthodonticsNubrace, Inc. · 2009
- 3 generations backK123514 Clearpath AlignerQserve America, Inc. · 2013
- 2 generations backK162609 ClearPath AlignerClearpath Orthodontics, Ltd. · 2017
- 1 generation backK202857 ClearPath AlignerClearpath Orthodontics, Ltd. · 2021
- This deviceK221097 SmileSeriesOrdont Orthodontic Laboratories, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK241137 Clear Moves AlignerClear Moves Aligners · 2024
Most influential descendants
Showing 1 of 1 · See all- K241137Clear Moves AlignerClear Moves Aligners · 2024 · cites it directly0descendants
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 | K073121 | Nubrace Invisible Removable Orthodontics | Nubrace, Inc. | 2009 | — |
| −3 | K123514 | Clearpath Aligner | Qserve America, Inc. | 2013 | — |
| −2 | K162609 | ClearPath Aligner | Clearpath Orthodontics, Ltd. | 2017 | — |
| −1 | K202857 | ClearPath Aligner | Clearpath Orthodontics, Ltd. | 2021 | — |
| 0 (this device) | K221097 | SmileSeries | Ordont Orthodontic Laboratories, Inc. | 2022 | — |
| +1 | K241137 | Clear Moves Aligner | Clear Moves Aligners | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K202857 | ClearPath AlignerSummary page 4…lassification Name Number Product Code Regulatory Class Orthodontic Plastic Bracket 21 CFR 872.5470 NXC 2 Review Panel Dental PREDICATE DEVICE Primary Predicate: K202857, ClearPath Aligner, ClearPath Orthodontics Reference Device: K180941 Ortho System™, 3Shape A/S DEVICE DESCRIPTION The SmileSer… | 2021 |
| † | K180941 | Ortho System | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241137 | Clear Moves Aligner | 2024 | 0 |
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 44 years and passes through 6 companies; a new generation was cleared every 4.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K241137 (Clear Moves Aligners, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K202857.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 SmileSeriesTM is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in adult and adolescent patients with permanent dentition (i.e. all second molars). The SmileSeriesTM 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/K221097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221097: SmileSeries.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221097
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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