510(k) · Cleared
ClearedDigiLine Direct Print Aligner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Park Dental Research Corporation · NXC Aligner, Sequential
Cleared on Apr 5, 2024 as substantially equivalent to K223355 (Graphy, Inc., 2022) after a 113-day review. Its family tree reaches back 8 generations to 1978.
- Decided
- Apr 5, 2024
- Review
- 113 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K780619 (1978). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 7 generations backK981095 Align SystemAlign Technology · 1998
- 6 generations backK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
- 5 generations backK082556 ClearcorrectClearcorrect, Inc. · 2009
- 4 generations backK113618 Clearcorrect SystemClearcorrect, Inc. · 2012
- 3 generations backK163689 3M Clear Tray Aligner3M Unitek Corporation · 2017
- 2 generations backK180107 Blue Sky Bio AlignerBlue Sky Bio, LLC · 2018
- 1 generation backK223355 Tera Harz ClearGraphy, Inc. · 2022
- This deviceK233935 DigiLine Direct Print Aligner SystemPark Dental Research Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −7 | K981095 | Align System | Align Technology | 1998 | — |
| −6 | K071970 | Clear Image Aligner | Specialty Appliance Works, Inc. | 2007 | — |
| −5 | K082556 | Clearcorrect | Clearcorrect, Inc. | 2009 | — |
| −4 | K113618 | Clearcorrect System | Clearcorrect, Inc. | 2012 | — |
| −3 | K163689 | 3M Clear Tray Aligner | 3M Unitek Corporation | 2017 | — |
| −2 | K180107 | Blue Sky Bio Aligner | Blue Sky Bio, LLC | 2018 | — |
| −1 | K223355 | Tera Harz Clear | Graphy, Inc. | 2022 | — |
| 0 (this device) | K233935 | DigiLine Direct Print Aligner System | Park Dental Research Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 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.
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 46 years and passes through 8 companies; a new generation was cleared every 4.7 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K223355.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 DigiLine Direct Print Aligner System is indicated for the treatment of tooth malocclusion in
patients with permanent dentition (i.e. all second molars). The DigiLine Direct Print Aligner System
repositions teeth by way of continuous gentle force.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233935 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233935: DigiLine Direct Print Aligner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233935
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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