Clear aligners: manufacturers and brands
69 companies make or specify clear aligners among the 83 that list one with FDA, under 174 brand and model names. FDA has issued 146 510(k) clearances in this category, 63 of them in the last five years.
510(k) clearances per year, 1976–2026
Clear aligner manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | REF03 ClearCorrect System Aligners (Multi-layer) · REF05 ClearCorrect System Aligner (Single Layer) | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Essix (Sports) Mouthguard · Essix A+ · Essix ACE · Essix C+ · +9 | 148 | 2026 |
| Dentis Co., Ltd. | South Korea | Maker | Mesheet | 37 | 2026 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | Additively Manufactured Aligner Resin | 16 | 2026 |
| Align Technology, Inc. | United States | Maker | iGo · iGo Plus · Invisalign ART · Invisalign Assist · +34 | 16 | 2026 |
| GC America Inc. | United States | Maker | Eon Aligner | 137 | 2026 |
| Sybron Dental Specialties | United States | Maker | Red, White, & Blue Retainer · SIMPLI5 · Spark Clear Aligner System | 203 | 2026 |
| Graphy, Inc. | South Korea | Maker | TERA HARZ CLEAR (TC-85DAC, TR-07, TA-28) | 6 | 2025 |
| Shandong Huge Dental Material Corporation | China | Maker | VinciSmile Invisible Orthodontic Appliance | 8 | 2026 |
| LuxCreo Inc. | United States | Maker | LuxCreo Clear Aligner System | 4 | 2026 |
| Blue Sky Bio, LLC | United States | Maker | Blue Sky Plan - Ortho Module · Blue Sky Plan Ortho Module | 20 | 2024 |
| Park Dental Research Corp | United States | Maker | Clear Moves · DigiLine · Park Dental Research Aligners · Six Month Smiles Aligners | 8 | 2026 |
| Bisco, Inc. | United States | Maker | — | 88 | 2025 |
| Smylio | United States | Maker | AirFlex Aligners · FXBright Aligner · FXClear Aligner · NiTime Aligners · +2 | 4 | 2026 |
| Modern Dental Laboratory Co., Ltd. | China | Maker | TRIOCLEAR System | 2 | 2024 |
| Zhejiang Yinchili Medical Technology Co.,Ltd | China | Maker | ClearCorrect System · Custom-made Invisible Aligners | 2 | 2023 |
| Tns Co., Ltd. | South Korea | Maker | Serafin® | 2 | 2025 |
| The Argen Corporation | United States | Maker | Aligner Premium · Aligner Retainer Premium · Aligner Retainer Std · Aligner Revision Premium · +13 | 11 | 2024 |
| Cdb Corporation | United States | Maker | HIT Clear Aligner · HIT Clear Aligners | 9 | 2022 |
| Dreve Dentamid GmbH | Germany | Maker | Primeprint Direct Aligner | 6 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | Refine | 5 | 2022 |
| uLab Systems, Inc. | United States | Maker | uLab Systems Dental Aligner | 4 | 2022 |
| Wuxi EA Medical Instruments Technologies Limited | China | Maker | Angel Aligner · Clear Aligner(EAB II) | 2 | 2023 |
| Mem Dental Technology Co., Ltd. | Taiwan | Maker | MEM Aligner | 2 | 2025 |
| Alien Milling Technologies | United States | Maker | Alien Aligners | 1 | 2024 |
| Creodent Hudson Valley | United States | Maker | CreoKorrekt Aligners | 1 | 2026 |
| ODS Co., Ltd. | South Korea | Maker | Clear Miracle | 1 | 2025 |
| Archform Inc. | United States | Maker | Form Aligners | 1 | 2021 |
| Beame Medical Technology (Shenzhen) Limited | China | Maker | Clear Aligner (SCF-3348) | 1 | 2026 |
| Cristaline Aligners GmbH | Germany | Maker | Cristaline Aligners · Sigma Aligners | 1 | 2024 |
| Kline Europe GmbH | Germany | Maker | — | 1 | 2022 |
| ClearMoves Aligners | Pakistan | Maker | Clear Moves Aligner | 1 | 2024 |
| Reliance Orthodontic Products, Inc. | United States | Maker | Perfect A Smile · Pontic Paint | 32 | 2021 |
| Brius | United States | Maker | BRIUS Aligner | 2 | 2021 |
| Clearpath Orthodontics | Pakistan | Maker | Clearpath Aligner | 2 | 2021 |
| 3D Diagnostix inc | United States | Maker | — | 1 | 2020 |
| Biotech Dental Smilers, SAS | France | Maker | Smilers | 1 | 2021 |
| ASO International Manila, Inc. | Philippines | Maker | — | 1 | 2021 |
| Royal Dental Laboratory | China | Maker | Clear Aligner | 1 | 2020 |
| Drake Precision Dental Laboratory, Inc. | United States | Maker | — | 1 | 2020 |
| Utah Medical Products and Services | United States | Maker | Archworx | 1 | 2021 |
| Inman Orthodontic Laboratories, Inc. | United States | Maker | Digital Clear Aligners (DCAs) | 1 | 2021 |
| Sun Dental Laboratories, LLC | United States | Maker | SunClear Aligner | 1 | 2019 |
| Vitang Technology LLC | United States | Maker | Unismile Clear Aligner | 1 | 2020 |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Maker | Tri-Aligner | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | Smart Moves Complete | — | — |
| Aditek do Brasil SA | Brazil | Maker | Clear Aligner (EAB II) | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Ortho Dental Lab, LLC | United States | Maker | Ortho Aligner System · SmileSet Aligners · SmileSet All-Day Aligners · SmileSet Nighttime Aligners · +1 | — | — |
| Ortho Solutions LC | United States | Maker | EZ Align | — | — |
| Xplora USA LLC | United States | Maker | Six Month Smiles | — | — |
| Specialty Appliances, LLC | United States | Maker | Clear Image Aligners · Clear Image® Aligner | — | — |
| Candid Care Co. | United States | Maker | Candid Aligner · Candid Aligner Kit FGS-0001, FGS-0002; Candid Care Replacement Kit FGS-0004; Candid Care Refinement Kit FGS-0008 · Candid Clear Aligner · FGS-2002 Glidewell Aligner Kit · +6 | — | — |
| Shenzhen Sunmc Dental Technology Co., Ltd. | China | Maker | Clear Aligner | — | — |
| Johns Dental Lab | United States | Maker | Redline · Redline Clear Aligner System | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Burbank Dental Lab | United States | Maker | — | — | — |
| Ningbo Sezen Technology Co., Ltd. | China | Maker | LuxCreo Clear Aligner System | — | — |
| Alta Smiles, Inc | United States | Maker | Alta-Clear | — | — |
| EXCELDENT Dental Technology Development Co., Ltd. | China | Maker | SunClear Aligner | — | — |
| Laxmi Dental Limited | India | Maker | Illusion Aligner Flx · Illusion Aligner Pro · Illusion Aligners | — | — |
| Microdental 2006 SL | Spain | Maker | Aligner Secuential · SMS aligner | — | — |
| Ohlendorf Company | United States | Maker | Clear Express · Clear Force | — | — |
| Angelalign Manufacturing Corp. | United States | Maker | — | — | — |
| Eon Dental Jordan (Free Zones) | Jordan | Maker | Sequential Aligner | — | — |
| GEO s.r.l. | Italy | Maker | Nuvola | — | — |
| New England Orthodontic Laboratory | United States | Maker | NEOLab Clear Aligners | — | — |
| Xi'an Henghui Technology, Ltd | China | Maker | — | — | — |
| Yin Li (Sichuan) Technology Inc | China | Maker | — | — | — |
| Ortho Organizers, Inc. | United States | Manufacturer | — | 8 | 2025 |
| Biotech Dental | United States | Manufacturer | Smilers | 1 | 2024 |
| Selane Products, Inc. | United States | Contract manufacturer | DigiLine Adirect Print Aligner System | 2 | 2017 |
| Beaming White LLC | United States | Manufacturer | SnapCorrect | — | — |
| Midwest Sterilization Corp. | United States | Contract sterilizer | Aligner, sequential | — | — |
| Axiom Marketing, Inc. | United States | Repacker / relabeler | Invisalign; Invisalign Aligner; Invisalign System - Moderate; Invisalign System | — | — |
| GLO Science, Inc. | United States | Contract manufacturer | Six Month Smiles Aligner | — | — |
| Shanghai Smartee Denti-Technology Co., Ltd. | China | Foreign exporter | Byte Aligner System · Custom-made Invisible Aligners · REF03 ClearCorrect System Aligners(Multi-layer) | — | — |
| Nuvola World S.R.L. | Italy | Foreign exporter | NUVOLA | — | — |
| Northstar Trade Co., Limited | China | Foreign exporter | SunClear Aligner | — | — |
| Shenb America, Inc. | United States | Lister | PlaDuo PRO System; PlaDuo System | — | — |
| Smile Perfect, LLC | United States | Repacker / relabeler | Smile Perfect | — | — |
| Smileie,Inc. | United States | Repacker / relabeler | Smileie | — | — |
| Xlur, LLC | United States | Repacker / relabeler | XLUR | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where clear aligners are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Sequential AlignerNXC | 2 | 872.5470 | 69 | 146 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 Oct 2026 | K263860 | Shining3D Clear Aligner System | Hangzhou SHINING3D Dental Technology Co., Ltd | NXC Sequential Aligner |
| 2 Jul 2026 | K260527 | FACE4D Aligner | Avinent Implant System S.L.U. | NXC Sequential Aligner |
| 8 May 2026 | K260788 | Smylio Aligners | Smylio | NXC Sequential Aligner |
| 15 Apr 2026 | K260722 | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | NXC Sequential Aligner |
| 3 Feb 2026 | K253282 | ZSmile System | Dror Orthodesign , Ltd. | NXC Sequential Aligner |
| 7 Jan 2026 | K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | NXC Sequential Aligner |
| 7 Nov 2025 | K250739 | Primeprint Direct Aligner | Dreve Dentamid GmbH | NXC Sequential Aligner |
| 23 Oct 2025 | K252931 | Invisalign® Palatal Expander System | Align Technology, Inc. | NXC Sequential Aligner |
| 9 Oct 2025 | K252870 | Invisalign Specifix Attachment System | Align Technology, Inc. | NXC Sequential Aligner |
| 11 Sep 2025 | K251758 | Serafin® | Tns Co., Ltd. | NXC Sequential Aligner |
| 29 Aug 2025 | K252380 | Invisalign System | Align Technology, Inc. | NXC Sequential Aligner |
| 27 Aug 2025 | K251415 | Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd | NXC Sequential Aligner |
| 22 Jul 2025 | K251616 | Clear Miracle | ODS Co., Ltd. | NXC Sequential Aligner |
| 21 May 2025 | K242637 | MEM Clear Aligner System | Mem Dental Technology Co., Ltd. | NXC Sequential Aligner |
| 8 Apr 2025 | K250343 | LuxCreo Clear Aligner System | LuxCreo Inc. | NXC Sequential Aligner |
| 20 Feb 2025 | K250487 | SparkTM Clear Aligner System | Sybron Dental Specialties | NXC Sequential Aligner |
| 16 Jan 2025 | K242715 | Pearl Clear Aligner | Pearl Digital, Inc. | NXC Sequential Aligner |
| 20 Dec 2024 | K242929 | Fas Aligner System | Xplora 3D Europe S.L | NXC Sequential Aligner |
| 19 Dec 2024 | K242892 | Cristaline Aligners Z FLX | Cristaline Aligners GmbH | NXC Sequential Aligner |
| 12 Dec 2024 | K233152 | GENIOVA aligners | Geniova Technologies Sociedad Limitada | NXC Sequential Aligner |
| 11 Oct 2024 | K240501 | Spark Clear Aligner System | Sybron Dental Specialties | NXC Sequential Aligner |
| 8 Aug 2024 | K233356 | Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. | NXC Sequential Aligner |
| 1 Aug 2024 | K241137 | Clear Moves Aligner | ClearMoves Aligners | NXC Sequential Aligner |
| 26 Jul 2024 | K241187 | Alien Aligners | Alien Milling Technologies | NXC Sequential Aligner |
| 18 Jun 2024 | K241412 | Invisalign System | Align Technology, Inc. | NXC Sequential Aligner |
| 5 Apr 2024 | K233935 | DigiLine Direct Print Aligner System | Park Dental Research Corp | NXC Sequential Aligner |
| 4 Apr 2024 | K240038 | Clear Moves Aligners | Space Maintainers Laboratories (Sml) | NXC Sequential Aligner |
| 3 Apr 2024 | K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | Blue Sky Bio, LLC | NXC Sequential Aligner |
| 5 Mar 2024 | K240597 | TERA HARZ CLEAR | Graphy, Inc. | NXC Sequential Aligner |
| 22 Feb 2024 | K233544 | MESHEET | Dentis Co., Ltd. | NXC Sequential Aligner |
| 22 Feb 2024 | K232074 | Serafin® | Tns Co., Ltd. | NXC Sequential Aligner |
| 15 Dec 2023 | K232887 | Invisalign Palatal Expander System | Align Technology, Inc. | NXC Sequential Aligner |
| 18 Oct 2023 | K230199 | Byte Aligner System | Dentsply Sirona, Inc. | NXC Sequential Aligner |
| 29 Sep 2023 | K233257 | 3M ClarityAligners with Quick Attachments | 3M Company, Unitek Orthodontic Products | NXC Sequential Aligner |
| 26 Sep 2023 | K232233 | Invisalign System with Mandibular Advancement Featuring Occlusal Blocks | Align Technology, Inc. | NXC Sequential Aligner |
| 1 Sep 2023 | K231884 | TRIOCLEAR System | Modern Dental Laboratory Co., Ltd. | NXC Sequential Aligner |
| 13 Jun 2023 | K223517 | Clear Aligner | Wuxi EA Medical Instruments Technologies Limited | NXC Sequential Aligner |
| 22 May 2023 | K231464 | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) | 3M Company, Unitek Orthodontic Products | NXC Sequential Aligner |
| 24 Apr 2023 | K223141 | STR8 Clear Aligner | Str8 Oral Care | NXC Sequential Aligner |
| 17 Apr 2023 | K223454 | Custom-made Invisible Aligners | Zhejiang Yinchili Medical Technology Co.,Ltd | NXC Sequential Aligner |