510(k) · Cleared
ClearedBlue Sky Bio Aligner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue Sky Bio, LLC · NXC Aligner, Sequential
Cleared on Feb 9, 2018 as substantially equivalent to K163689 (3M Unitek Corporation, 2017) after a 24-day review. Its family tree reaches back 6 generations to 1978. 4 later devices descend from it.
- Decided
- Feb 9, 2018
- Review
- 24 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K780619 (1978). 9 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 5 generations backK981095 Align SystemAlign Technology · 1998
- 4 generations backK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
- 3 generations backK082556 ClearcorrectClearcorrect, Inc. · 2009
- 2 generations backK113618 Clearcorrect SystemClearcorrect, Inc. · 2012
- 1 generation backK163689 3M Clear Tray Aligner3M Unitek Corporation · 2017
- This deviceK180107 Blue Sky Bio AlignerBlue Sky Bio, LLC · 2018
- Descendant · cites it directly · 2 of its ownK223355 Tera Harz ClearGraphy, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK251616 Clear MiracleOds Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK233935 DigiLine Direct Print Aligner SystemPark Dental Research Corporation · 2024
- Descendant · cites it directly · 0 of its ownK240597 Tera Harz ClearGraphy, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K223355Tera Harz ClearGraphy, Inc. · 2022 · cites it directly2descendants
- K251616Clear MiracleOds Co., Ltd. · 2025 · 2 generations on0descendants
- K233935DigiLine Direct Print Aligner SystemPark Dental Research Corporation · 2024 · 2 generations on0descendants
- K240597Tera Harz ClearGraphy, Inc. · 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 | K071970 | Clear Image Aligner | Specialty Appliance Works, Inc. | 2007 | — |
| −3 | K082556 | Clearcorrect | Clearcorrect, Inc. | 2009 | — |
| −2 | K113618 | Clearcorrect System | Clearcorrect, Inc. | 2012 | — |
| −1 | K163689 | 3M Clear Tray Aligner | 3M Unitek Corporation | 2017 | — |
| 0 (this device) | K180107 | Blue Sky Bio Aligner | Blue Sky Bio, LLC | 2018 | — |
| +1 | K223355 | Tera Harz Clear | Graphy, Inc. | 2022 | — |
| +2 | K251616 | Clear Miracle | Ods Co., Ltd. | 2025 | — |
| +2 | K233935 | DigiLine Direct Print Aligner System | Park Dental Research Corporation | 2024 | — |
| +1 | K240597 | Tera Harz Clear | Graphy, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K163689 | 3M Clear Tray AlignerSummary page 6…e Sky Bio Aligners Common Name Sequential Aligner Predicate 510(k) 3M Clear Tray Aligner K163689 Reference Predicates Blue Sky Plan K090607 and Dentsply Essix… | 2017 |
| † | K090607 | Blue Sky Bio Plan, Version .38 | 2009 |
| † | K062828 | Mouthguard and Aligner Materials | 2006 |
What descends from it? (4)
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 40 years and passes through 6 companies; a new generation was cleared every 4.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K223355 (Graphy, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K163689.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Blue Sky Bio Aligners are a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially 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/K180107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180107: Blue Sky Bio Aligner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180107
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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