510(k) · Cleared
ClearedComposite Aligner Button
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Interntional · NXC Aligner, Sequential
Cleared on Apr 11, 2008 as substantially equivalent to K981095 (Align Technology, 1998) and 1 other predicate after a 71-day review. Its family tree reaches back 4 generations to 1978.
- Decided
- Apr 11, 2008
- Review
- 71 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K780619 (1978). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 3 generations backK981095 Align SystemAlign Technology · 1998
- 2 generations backK062828 Mouthguard and Aligner MaterialsDentsply Intl., Inc. · 2006
- 1 generation backK072522 Thermoform Sheet Materials and AccessoriesDentsply International, Inc. · 2007
- This deviceK080246 Composite Aligner ButtonDentsply Interntional · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −3 | K981095 | Align System | Align Technology | 1998 | — |
| −2 | K062828 | Mouthguard and Aligner Materials | Dentsply Intl., Inc. | 2006 | — |
| −1 | K072522 | Thermoform Sheet Materials and Accessories | Dentsply International, Inc. | 2007 | — |
| 0 (this device) | K080246 | Composite Aligner Button | Dentsply Interntional | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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? (2)
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…ALIGNER BUTFON CLASSIFICATION NAME: Sequential Aligner NXC 872.5470 PREDICATE DEVICES: Align System K981095 Thermoform Sheet Materials and Accessories K072522 DEVICE DESCRIPTION: The COMPOSIT… | 1998 |
| * | K072522 | Thermoform Sheet Materials and AccessoriesSummary page 1…872.5470 PREDICATE DEVICES: Align System K981095 Thermoform Sheet Materials and Accessories K072522 DEVICE DESCRIPTION: The COMPOSITE ALIGNER BUTTON is made of plastic and is bonded to an aligner for attaching elast… | 2007 |
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 30 years and passes through 5 companies; a new generation was cleared every 8.2 years on median.
- None of the 8 ancestors has a recall.
- 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. 2008, 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 COMPOSITE ALIGNER BUTTON is an accessory that is attached to dental or orthodontic aligners to assist in minor tooth movement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080246 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080246: Composite Aligner Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080246
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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