510(k) · Cleared
ClearedFACE4D Aligner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avinent Implant System S.L.U. · NXC Aligner, Sequential
Cleared on Jul 2, 2026 as substantially equivalent to K220726 (Kline Europe GmbH, 2022) after a 135-day review. Its family tree reaches back 7 generations to 1978.
- Decided
- Jul 2, 2026
- Review
- 135 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K780619 (1978). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 6 generations backK981095 Align SystemAlign Technology · 1998
- 5 generations backK081960 Invisalign SystemAlign Technology · 2008
- 4 generations backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- 3 generations backK203737 Spark Clear Aligner SystemOrmco Corporation · 2021
- 2 generations backK212660 Smylio Invisible Clear AlignersSmylio, Inc. · 2021
- 1 generation backK220726 K ClearKline Europe GmbH · 2022
- This deviceK260527 FACE4D AlignerAvinent Implant System S.L.U. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −6 | K981095 | Align System | Align Technology | 1998 | — |
| −5 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −4 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| −3 | K203737 | Spark Clear Aligner System | Ormco Corporation | 2021 | — |
| −2 | K212660 | Smylio Invisible Clear Aligners | Smylio, Inc. | 2021 | — |
| −1 | K220726 | K Clear | Kline Europe GmbH | 2022 | — |
| 0 (this device) | K260527 | FACE4D Aligner | Avinent Implant System S.L.U. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K220726 | K ClearSummary page 6…ed treatment plan to achieve orthodontic movement. Testing Summary: The material used for the FACE4D is the same thermoplastic polyurethane- polyester as that cleared in K220726 K Clear Align. A biocompatibility assessment is included. Avinent conducted manufacturing validation with Vision by SoftSmile (K2… | 2022 |
| † | K220287 | Invisalign System | 2022 |
| † | K212770 | Vision | 2021 |
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 48 years and passes through 7 companies; a new generation was cleared every 5.3 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
FACE4D aligners are indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260527: FACE4D Aligner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260527
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026