FDA product code NXC: Aligner, Sequential
NXC is the FDA product code for aligner, sequential. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel. FDA has cleared 145 510(k) submissions under NXC, 62 in the last five years, from 106 different applicants. The average 510(k) review took 169 days (median 128); 123 days on average over the last three years. FDA has posted 2 recalls for NXC devices, 2 initiated in the last five years.
Definition
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.
Classification
| Field | Value |
|---|---|
| Device name | Aligner, Sequential |
| Device class | Class II |
| Regulation | 21 CFR 872.5470 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NXC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 135 |
| 2018 | 11 | 136 |
| 2019 | 16 | 192 |
| 2020 | 16 | 203 |
| 2021 | 20 | 193 |
| 2022 | 19 | 185 |
| 2023 | 13 | 146 |
| 2024 | 14 | 153 |
| 2025 | 11 | 96 |
| 2026 | 5 | 120 |
Compare with all 510(k) review times · Search every NXC clearance
Top NXC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Align Technology, Inc. | 10 | 2025-10-23 |
| Smylio, Inc. | 4 | 2026-05-08 |
| Ormco Corporation | 3 | 2025-02-20 |
| Blue Sky Bio, LLC | 3 | 2024-04-03 |
| 3M Company, Unitek Orthodontic Products | 3 | 2023-09-29 |
101 more applicants have NXC clearances. See the full list in Caduvo.
Most recent NXC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260527 | Avinent Implant System S.L.U. | FACE4D Aligner | 2026-07-02 | 135 |
| K260788 | Smylio, Inc. | Smylio Aligners | 2026-05-08 | 59 |
| K260722 | Dentsply Sirona, Inc. | SureSmile Aligner (ASSY500020) | 2026-04-15 | 41 |
| K253282 | Dror Orthodesign , Ltd. | ZSmile System | 2026-02-03 | 127 |
| K251454 | Beame Medical Technology (Shenzhen) Limited | Clear Aligner (SCF-3348) | 2026-01-07 | 240 |
Recalls for NXC devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-11-22.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code NXC?
NXC is the FDA product code for aligner, sequential. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel.
What device class is NXC?
Class II, regulation 21 CFR 872.5470. Typical premarket route: 510(k).
How long does a 510(k) take for product code NXC?
Across 145 cleared submissions the average was 169 days from receipt to decision (median 128).
Which companies have the most NXC clearances?
Align Technology, Inc. (10); Smylio, Inc. (4); Ormco Corporation (3); Blue Sky Bio, LLC (3); 3M Company, Unitek Orthodontic Products (3).
Have NXC devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-11-22.
Next steps
- Run an FDA pathway report with predicate devices for product code NXC
- Run a recall and safety report across every NXC manufacturer
- Watch product code NXC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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