510(k) · Cleared
ClearedClear Aligner (SCF-3348)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beame Medical Technology (Shenzhen) Limited · NXC Aligner, Sequential
Cleared on Jan 7, 2026 as substantially equivalent to K233356 (Laxmi Dental Export Pvt., Ltd., 2024) and 1 other predicate after a 240-day review. Its family tree reaches back 8 generations to 1978.
- Decided
- Jan 7, 2026
- Review
- 240 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K780619 (1978). 16 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 backK182329 SureCure Orthodontic Aligner SystemDigital Orthodontic Care · 2018
- 2 generations backK212803 DailyMate Orthodontic Aligner System3D Global Biotech, Inc. · 2022
- 1 generation backK233356 Illusion Aligner Pro: Illusion Aligner FLXLaxmi Dental Export Pvt., Ltd. · 2024
- This deviceK251454 Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited · 2026
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 | K182329 | SureCure Orthodontic Aligner System | Digital Orthodontic Care | 2018 | — |
| −2 | K212803 | DailyMate Orthodontic Aligner System | 3D Global Biotech, Inc. | 2022 | — |
| −1 | K233356 | Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. | 2024 | — |
| 0 (this device) | K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K233356 | Illusion Aligner Pro: Illusion Aligner FLXSummary page 6…) Mode of action: Continuous gentle force applied to teeth to achieve movement. d) Manufacturing method: Thermoforming Both the subject device and the predicate device (K233356) are custom-made aligners manufactured using the same material - thermoplastic polyurethane - and using the same manufacturing me… | 2024 |
| * | K230237 | Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76…Summary page 6…ll indications for use, thereby supporting substantial equivalence. Furthermore, the raw materials for the subject device are sourced directly from the reference device (K230237). According to the production process of Clear Aligner, manufacturing involves first using software to print molds via 3D-printin… | 2023 |
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 8 companies; a new generation was cleared every 3.5 years on median.
- None of the 16 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?
Clear Aligner is indicated for use in the alignment of permanent teeth (i.e., all second molars) through orthodontic treatment of misalignment and malocclusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251454: Clear Aligner (SCF-3348).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251454
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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