510(k) · Cleared
ClearedULab Systems Dental Aligner Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulab Systems, Inc. · NXC Aligner, Sequential
Cleared on Feb 11, 2020 as substantially equivalent to K180241 (Ortho Caps GmbH, 2018) after a 144-day review. Its family tree reaches back 6 generations to 1978. 8 later devices descend from it.
- Decided
- Feb 11, 2020
- Review
- 144 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. 8 later devices descend from it, 4 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 backK180241 Orthocaps TwinalignerOrtho Caps GmbH · 2018
- This deviceK192596 ULab Systems Dental Aligner KitUlab Systems, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK212680 LuxCreo Clear Aligner SystemLuxCreo, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK232653 Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio…Blue Sky Bio, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK250739 Primeprint Direct AlignerDreve Dentamid GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK251415 Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242637 MEM Clear Aligner SystemMem Dental Technology Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K212680LuxCreo Clear Aligner SystemLuxCreo, Inc. · 2022 · cites it directly3descendants
- K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC · 2024 · cites it directly1descendant
- K250739Primeprint Direct AlignerDreve Dentamid GmbH · 2025 · 2 generations on0descendants
- K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K242637MEM Clear Aligner SystemMem Dental Technology Co., Ltd. · 2025 · 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 | K180241 | Orthocaps Twinaligner | Ortho Caps GmbH | 2018 | — |
| 0 (this device) | K192596 | ULab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2020 | — |
| +1 | K212680 | LuxCreo Clear Aligner System | LuxCreo, Inc. | 2022 | — |
| +1 | K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | Blue Sky Bio, LLC | 2024 | — |
| +2 | K250739 | Primeprint Direct Aligner | Dreve Dentamid GmbH | 2025 | — |
| +2 | K251415 | Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025 | — |
| +1 | K242637 | MEM Clear Aligner System | Mem Dental Technology Co., Ltd. | 2025 | — |
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 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K180241 | Orthocaps TwinalignerSummary page 4…tion Regulation: 21CFR 872.5470 Device Class: II Product Code: NXC Primary Predicate: Ortho Caps GmBH Orthocaps Twinaligner, K180241 Reference Predicates: Derby Dental Laboratory Custom Clear Aligner System, K173785 Sybron Dental Specialties Ormco Spark Aligner… | 2018 |
| † | K173785 | Custom Clear Aligner System | 2018 |
| † | K182826 | Ormco Spark Aligner System | 2018 |
| † | K171295 | ULab Systems Treatment Planning Software | 2018 |
What descends from it? (8)
4 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 6 companies; a new generation was cleared every 6.5 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K212680 (LuxCreo, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K180241.
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?
The uLab Systems Dental Aligner is indicated for the alignment of permanent teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192596: ULab Systems Dental Aligner Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192596
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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