Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart F — Therapeutic Devices](/submissions/DE/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 872.5470](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5470) → NXC — Aligner, Sequential # NXC · Aligner, Sequential _Dental · 21 CFR 872.5470 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC ## Overview - **Product Code:** NXC - **Device Name:** Aligner, Sequential - **Regulation:** [21 CFR 872.5470](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5470) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## Identification An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 143) Showing 20 most recent of 143 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260722](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K260722.md) | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | Apr 15, 2026 | SESE | | [K253282](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K253282.md) | ZSmile System | Dror Orthodesign , Ltd. | Feb 3, 2026 | SESE | | [K251454](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K251454.md) | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | Jan 7, 2026 | SESE | | [K250739](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K250739.md) | Primeprint Direct Aligner | Dreve Dentamid GmbH | Nov 7, 2025 | SESE | | [K252931](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K252931.md) | Invisalign® Palatal Expander System | Align Technology, Inc. | Oct 23, 2025 | SESE | | [K252870](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K252870.md) | Invisalign Specifix Attachment System | Align Technology, Inc. | Oct 9, 2025 | SESE | | [K251758](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K251758.md) | Serafin® | Tns Co., Ltd. | Sep 11, 2025 | SESE | | [K252380](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K252380.md) | Invisalign System | Align Technology, Inc. | Aug 29, 2025 | SESE | | [K251415](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K251415.md) | Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | Aug 27, 2025 | SESE | | [K251616](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K251616.md) | Clear Miracle | Ods Co., Ltd. | Jul 22, 2025 | SESE | | [K242637](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K242637.md) | MEM Clear Aligner System | Mem Dental Technology Co., Ltd. | May 21, 2025 | SESE | | [K250343](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K250343.md) | LuxCreo Clear Aligner System | LuxCreo, Inc. | Apr 8, 2025 | SESE | | [K250487](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K250487.md) | SparkTM Clear Aligner System | Ormco Corporation | Feb 20, 2025 | SESE | | [K242715](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K242715.md) | Pearl Clear Aligner | Pearl Digital, Inc. | Jan 16, 2025 | SESE | | [K242929](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K242929.md) | Fas Aligner System | Xplora 3D Europe S.L | Dec 20, 2024 | SESE | | [K242892](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K242892.md) | Cristaline Aligners Z FLX | Cristaline Aligners GmbH | Dec 19, 2024 | SESE | | [K233152](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K233152.md) | GENIOVA aligners | Geniova Technologies Sociedad Limitada | Dec 12, 2024 | SESE | | [K240501](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K240501.md) | Spark™ Clear Aligner System | Ormco Corporation | Oct 11, 2024 | SESE | | [K233356](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K233356.md) | Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. | Aug 8, 2024 | SESE | | [K241137](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K241137.md) | Clear Moves Aligner | Clear Moves Aligners | Aug 1, 2024 | SESE | ## Top Applicants - Align Technology, Inc. — 10 clearances - 3M Company, Unitek Orthodontic Products — 3 clearances - Blue Sky Bio, LLC — 3 clearances - Ormco Corporation — 3 clearances - Smylio, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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