NXC · Aligner, Sequential
Dental · 21 CFR 872.5470 · Class 2
Overview
| Product Code | NXC |
|---|---|
| Device Name | Aligner, Sequential |
| Regulation | 21 CFR 872.5470 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | Apr 15, 2026 | SESE |
| K253282 | ZSmile System | Dror Orthodesign , Ltd. | Feb 3, 2026 | SESE |
| K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | Jan 7, 2026 | SESE |
| K250739 | Primeprint Direct Aligner | Dreve Dentamid GmbH | Nov 7, 2025 | SESE |
| K252931 | Invisalign® Palatal Expander System | Align Technology, Inc. | Oct 23, 2025 | SESE |
| K252870 | Invisalign Specifix Attachment System | Align Technology, Inc. | Oct 9, 2025 | SESE |
| K251758 | Serafin® | Tns Co., Ltd. | Sep 11, 2025 | SESE |
| K252380 | Invisalign System | Align Technology, Inc. | Aug 29, 2025 | SESE |
| K251415 | Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | Aug 27, 2025 | SESE |
| K251616 | Clear Miracle | Ods Co., Ltd. | Jul 22, 2025 | SESE |
| K242637 | MEM Clear Aligner System | Mem Dental Technology Co., Ltd. | May 21, 2025 | SESE |
| K250343 | LuxCreo Clear Aligner System | LuxCreo, Inc. | Apr 8, 2025 | SESE |
| K250487 | SparkTM Clear Aligner System | Ormco Corporation | Feb 20, 2025 | SESE |
| K242715 | Pearl Clear Aligner | Pearl Digital, Inc. | Jan 16, 2025 | SESE |
| K242929 | Fas Aligner System | Xplora 3D Europe S.L | Dec 20, 2024 | SESE |
| K242892 | Cristaline Aligners Z FLX | Cristaline Aligners GmbH | Dec 19, 2024 | SESE |
| K233152 | GENIOVA aligners | Geniova Technologies Sociedad Limitada | Dec 12, 2024 | SESE |
| K240501 | Spark Clear Aligner System | Ormco Corporation | Oct 11, 2024 | SESE |
| K233356 | Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. | Aug 8, 2024 | SESE |
| K241137 | Clear Moves Aligner | Clear Moves Aligners | Aug 1, 2024 | SESE |
Top Applicants
- Align Technology, Inc. — 10 clearances
- Smylio, Inc. — 3 clearances
- Ormco Corporation — 3 clearances
- Blue Sky Bio, LLC — 3 clearances
- 3M Company, Unitek Orthodontic Products — 3 clearances
