510(k) · Cleared
ClearedNubrace Invisible Removable Orthodontics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nubrace, Inc. · NXC Aligner, Sequential
Cleared on Feb 12, 2009 as substantially equivalent to K981095 (Align Technology, 1998) after a 465-day review. Its family tree reaches back 2 generations to 1978. 7 later devices descend from it.
- Decided
- Feb 12, 2009
- Review
- 465 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K780619 (1978). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 1 generation backK981095 Align SystemAlign Technology · 1998
- This deviceK073121 Nubrace Invisible Removable OrthodonticsNubrace, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK123514 Clearpath AlignerQserve America, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK162609 ClearPath AlignerClearpath Orthodontics, Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK202857 ClearPath AlignerClearpath Orthodontics, Ltd. · 2021
- Descendant · 4 generations on · 1 of its ownK221097 SmileSeriesOrdont Orthodontic Laboratories, Inc. · 2022
- Descendant · 5 generations on · 0 of its ownK241137 Clear Moves AlignerClear Moves Aligners · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K123514Clearpath AlignerQserve America, Inc. · 2013 · cites it directly6descendants
- K162609ClearPath AlignerClearpath Orthodontics, Ltd. · 2017 · 2 generations on4descendants
- K202857ClearPath AlignerClearpath Orthodontics, Ltd. · 2021 · 3 generations on3descendants
- K221097SmileSeriesOrdont Orthodontic Laboratories, Inc. · 2022 · 4 generations on1descendant
- K241137Clear Moves AlignerClear Moves Aligners · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −1 | K981095 | Align System | Align Technology | 1998 | — |
| 0 (this device) | K073121 | Nubrace Invisible Removable Orthodontics | Nubrace, Inc. | 2009 | — |
| +1 | K123514 | Clearpath Aligner | Qserve America, Inc. | 2013 | — |
| +2 | K162609 | ClearPath Aligner | Clearpath Orthodontics, Ltd. | 2017 | — |
| +3 | K202857 | ClearPath Aligner | Clearpath Orthodontics, Ltd. | 2021 | — |
| +4 | K221097 | SmileSeries | Ordont Orthodontic Laboratories, Inc. | 2022 | — |
| +5 | K241137 | Clear Moves Aligner | Clear Moves Aligners | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K981095 | Align SystemSummary page 1…ame Invisible Removable Orthodontic Stint Classification Name Preformed Tooth Positioner Predicate Device Align Technology, Inc.'s Align System (K98 1095) Intended Use / Indications for Use The NuBrace IRO is indicated for the treatment of tooth malocclusion and for pre-… | 1998 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123514 | Clearpath Aligner | 2013 | 6 |
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 31 years and passes through 3 companies; a new generation was cleared every 20.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K123514 (Qserve America, Inc., 2013) has gone furthest, with 6 descendants of its own.
- 8 other devices also cite its predicate K981095.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 NuBrace IRO is indicated for the treatment of tooth malocclusion and for pre-prosthetic orthodontic cosmetic movement in patients with permanent dentition (i.e., all second molars).
The NuBrace IRO is intended to position teeth by way of continuous gentle force.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073121: Nubrace Invisible Removable Orthodontics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073121
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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