510(k) · Cleared
ClearedGENIOVA aligners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geniova Technologies Sociedad Limitada · NXC Aligner, Sequential
Cleared on Dec 12, 2024 as substantially equivalent to K202792 (Brius Technologies, Inc., 2021) after a 442-day review. Its family tree reaches back 8 generations to 1978.
- Decided
- Dec 12, 2024
- Review
- 442 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 backK180241 Orthocaps TwinalignerOrtho Caps GmbH · 2018
- 2 generations backK191838 Clearform AlignersMotor City Lab Works · 2020
- 1 generation backK202792 BRIUS Clear AlignersBrius Technologies, Inc. · 2021
- This deviceK233152 GENIOVA alignersGeniova Technologies Sociedad Limitada · 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 | K180241 | Orthocaps Twinaligner | Ortho Caps GmbH | 2018 | — |
| −2 | K191838 | Clearform Aligners | Motor City Lab Works | 2020 | — |
| −1 | K202792 | BRIUS Clear Aligners | Brius Technologies, Inc. | 2021 | — |
| 0 (this device) | K233152 | GENIOVA aligners | Geniova Technologies Sociedad Limitada | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K202792 | BRIUS Clear AlignersSummary page 5…roduct Code: NXC – Orthodontic plastic bracket Predicate Device Information Predicate Device: K202792 – BRIUS Clear Aligners Reference Device: K180941 – Ortho System K062828… | 2021 |
| † | K180941 | Ortho System | 2018 |
| † | K062828 | Mouthguard and Aligner Materials | 2006 |
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 3.9 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K202792.
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?
GENIOVA Aligners are indicated for use in the alignment of permanent teeth (i.e., all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.
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/K233152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233152: GENIOVA aligners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233152
Report an extraction error
Are you the manufacturer?
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