Dental Device Guide
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Therapeutic devices · 21 CFR 872 Subpart F

Sequential Aligner

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

FDA codeNXCClass221 CFR872.5470Pathway510(k)CategoryClear aligners
Companies listing it
8369 makers
Brands and models
174
510(k) clearances
14663 in five years
FDA name
Aligner, Sequential
1998: 12004: 12007: 12008: 22009: 22010: 12012: 22013: 42015: 22016: 12017: 32018: 112019: 162020: 162021: 202022: 192023: 132024: 142025: 112026: 619801990200020102020

510(k) clearances per year, 1976–2026

Companies that list NXC

83 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Institut Straumann AGSwitzerlandMakerREF03 ClearCorrect System Aligners (Multi-layer) · REF05 ClearCorrect System Aligner (Single Layer)2122026
Dentsply Sirona, Inc.United StatesMakerEssix (Sports) Mouthguard · Essix A+ · Essix ACE · Essix C+ · +91482026
Dentis Co., Ltd.South KoreaMakerMesheet372026
Aidite (Qinhuangdao) Technology Co., LtdChinaMakerAdditively Manufactured Aligner Resin162026
Align Technology, Inc.United StatesMakeriGo · iGo Plus · Invisalign ART · Invisalign Assist · +34162026
GC America Inc.United StatesMakerEon Aligner1372026
Sybron Dental SpecialtiesUnited StatesMakerRed, White, & Blue Retainer · SIMPLI5 · Spark Clear Aligner System2032026
Graphy, Inc.South KoreaMakerTERA HARZ CLEAR (TC-85DAC, TR-07, TA-28)62025
Shandong Huge Dental Material CorporationChinaMakerVinciSmile Invisible Orthodontic Appliance82026
LuxCreo Inc.United StatesMakerLuxCreo Clear Aligner System42026
Blue Sky Bio, LLCUnited StatesMakerBlue Sky Plan - Ortho Module · Blue Sky Plan Ortho Module202024
Park Dental Research CorpUnited StatesMakerClear Moves · DigiLine · Park Dental Research Aligners · Six Month Smiles Aligners82026
Bisco, Inc.United StatesMaker—882025
SmylioUnited StatesMakerAirFlex Aligners · FXBright Aligner · FXClear Aligner · NiTime Aligners · +242026
Modern Dental Laboratory Co., Ltd.ChinaMakerTRIOCLEAR System22024
Zhejiang Yinchili Medical Technology Co.,LtdChinaMakerClearCorrect System · Custom-made Invisible Aligners22023
Tns Co., Ltd.South KoreaMakerSerafin®22025
The Argen CorporationUnited StatesMakerAligner Premium · Aligner Retainer Premium · Aligner Retainer Std · Aligner Revision Premium · +13112024
Cdb CorporationUnited StatesMakerHIT Clear Aligner · HIT Clear Aligners92022
Dreve Dentamid GmbHGermanyMakerPrimeprint Direct Aligner62025
Tp Orthodontics, Inc.United StatesMakerRefine52022
uLab Systems, Inc.United StatesMakeruLab Systems Dental Aligner42022
Wuxi EA Medical Instruments Technologies LimitedChinaMakerAngel Aligner · Clear Aligner(EAB II)22023
Mem Dental Technology Co., Ltd.TaiwanMakerMEM Aligner22025
Alien Milling TechnologiesUnited StatesMakerAlien Aligners12024
Creodent Hudson ValleyUnited StatesMakerCreoKorrekt Aligners12026
ODS Co., Ltd.South KoreaMakerClear Miracle12025
Archform Inc.United StatesMakerForm Aligners12021
Beame Medical Technology (Shenzhen) LimitedChinaMakerClear Aligner (SCF-3348)12026
Cristaline Aligners GmbHGermanyMakerCristaline Aligners · Sigma Aligners12024
Kline Europe GmbHGermanyMaker—12022
ClearMoves AlignersPakistanMakerClear Moves Aligner12024
Reliance Orthodontic Products, Inc.United StatesMakerPerfect A Smile · Pontic Paint322021
BriusUnited StatesMakerBRIUS Aligner22021
Clearpath OrthodonticsPakistanMakerClearpath Aligner22021
3D Diagnostix incUnited StatesMaker—12020
Biotech Dental Smilers, SASFranceMakerSmilers12021
ASO International Manila, Inc.PhilippinesMaker—12021
Royal Dental LaboratoryChinaMakerClear Aligner12020
Drake Precision Dental Laboratory, Inc.United StatesMaker—12020
Utah Medical Products and ServicesUnited StatesMakerArchworx12021
Inman Orthodontic Laboratories, Inc.United StatesMakerDigital Clear Aligners (DCAs)12021
Sun Dental Laboratories, LLCUnited StatesMakerSunClear Aligner12019
Vitang Technology LLCUnited StatesMakerUnismile Clear Aligner12020
Five Star Orthodontic Laboratory & Supply, Inc.United StatesMakerTri-Aligner——
Great Lakes Dental Technologies, Ltd.United StatesMakerSmart Moves Complete——
Aditek do Brasil SABrazilMakerClear Aligner (EAB II)——
Solventum US LLCUnited StatesMaker———
Ortho Dental Lab, LLCUnited StatesMakerOrtho Aligner System · SmileSet Aligners · SmileSet All-Day Aligners · SmileSet Nighttime Aligners · +1——
Ortho Solutions LCUnited StatesMakerEZ Align——
Xplora USA LLCUnited StatesMakerSix Month Smiles——
Specialty Appliances, LLCUnited StatesMakerClear Image Aligners · Clear Image® Aligner——
Candid Care Co.United StatesMakerCandid 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.ChinaMakerClear Aligner——
Johns Dental LabUnited StatesMakerRedline · Redline Clear Aligner System——
Peter Brasseler Holdings, LLCUnited StatesMaker———
Burbank Dental LabUnited StatesMaker———
Ningbo Sezen Technology Co., Ltd.ChinaMakerLuxCreo Clear Aligner System——
Alta Smiles, IncUnited StatesMakerAlta-Clear——
EXCELDENT Dental Technology Development Co., Ltd.ChinaMakerSunClear Aligner——
Laxmi Dental LimitedIndiaMakerIllusion Aligner Flx · Illusion Aligner Pro · Illusion Aligners——
Microdental 2006 SLSpainMakerAligner Secuential · SMS aligner——
Ohlendorf CompanyUnited StatesMakerClear Express · Clear Force——
Angelalign Manufacturing Corp.United StatesMaker———
Eon Dental Jordan (Free Zones)JordanMakerSequential Aligner——
GEO s.r.l.ItalyMakerNuvola——
New England Orthodontic LaboratoryUnited StatesMakerNEOLab Clear Aligners——
Xi'an Henghui Technology, LtdChinaMaker———
Yin Li (Sichuan) Technology IncChinaMaker———
Ortho Organizers, Inc.United StatesManufacturer—82025
Biotech DentalUnited StatesManufacturerSmilers12024
Selane Products, Inc.United StatesContract manufacturerDigiLine Adirect Print Aligner System22017
Beaming White LLCUnited StatesManufacturerSnapCorrect——
Midwest Sterilization Corp.United StatesContract sterilizerAligner, sequential——
Axiom Marketing, Inc.United StatesRepacker / relabelerInvisalign; Invisalign Aligner; Invisalign System - Moderate; Invisalign System——
GLO Science, Inc.United StatesContract manufacturerSix Month Smiles Aligner——
Shanghai Smartee Denti-Technology Co., Ltd.ChinaForeign exporterByte Aligner System · Custom-made Invisible Aligners · REF03 ClearCorrect System Aligners(Multi-layer)——
Nuvola World S.R.L.ItalyForeign exporterNUVOLA——
Northstar Trade Co., LimitedChinaForeign exporterSunClear Aligner——
Shenb America, Inc.United StatesListerPlaDuo PRO System; PlaDuo System——
Smile Perfect, LLCUnited StatesRepacker / relabelerSmile Perfect——
Smileie,Inc.United StatesRepacker / relabelerSmileie——
Xlur, LLCUnited StatesRepacker / relabelerXLUR——

510(k) clearances

Decided510(k)DeviceApplicant
30 Oct 2026K263860Shining3D Clear Aligner SystemHangzhou SHINING3D Dental Technology Co., Ltd
2 Jul 2026K260527FACE4D AlignerAvinent Implant System S.L.U.
8 May 2026K260788Smylio AlignersSmylio
15 Apr 2026K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.
3 Feb 2026K253282ZSmile SystemDror Orthodesign , Ltd.
7 Jan 2026K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited
7 Nov 2025K250739Primeprint Direct AlignerDreve Dentamid GmbH
23 Oct 2025K252931Invisalign® Palatal Expander SystemAlign Technology, Inc.
9 Oct 2025K252870Invisalign Specifix Attachment SystemAlign Technology, Inc.
11 Sep 2025K251758Serafin®Tns Co., Ltd.
29 Aug 2025K252380Invisalign SystemAlign Technology, Inc.
27 Aug 2025K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd
22 Jul 2025K251616Clear MiracleODS Co., Ltd.
21 May 2025K242637MEM Clear Aligner SystemMem Dental Technology Co., Ltd.
8 Apr 2025K250343LuxCreo Clear Aligner SystemLuxCreo Inc.
20 Feb 2025K250487SparkTM Clear Aligner SystemSybron Dental Specialties
16 Jan 2025K242715Pearl Clear AlignerPearl Digital, Inc.
20 Dec 2024K242929Fas Aligner SystemXplora 3D Europe S.L
19 Dec 2024K242892Cristaline Aligners Z FLXCristaline Aligners GmbH
12 Dec 2024K233152GENIOVA alignersGeniova Technologies Sociedad Limitada
11 Oct 2024K240501Spark™ Clear Aligner SystemSybron Dental Specialties
8 Aug 2024K233356Illusion Aligner Pro: Illusion Aligner FLXLaxmi Dental Export Pvt., Ltd.
1 Aug 2024K241137Clear Moves AlignerClearMoves Aligners
26 Jul 2024K241187Alien AlignersAlien Milling Technologies
18 Jun 2024K241412Invisalign SystemAlign Technology, Inc.
5 Apr 2024K233935DigiLine Direct Print Aligner SystemPark Dental Research Corp
4 Apr 2024K240038Clear Moves AlignersSpace Maintainers Laboratories (Sml)
3 Apr 2024K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC
5 Mar 2024K240597TERA HARZ CLEARGraphy, Inc.
22 Feb 2024K233544MESHEETDentis Co., Ltd.
22 Feb 2024K232074Serafin®Tns Co., Ltd.
15 Dec 2023K232887Invisalign Palatal Expander SystemAlign Technology, Inc.
18 Oct 2023K230199Byte Aligner SystemDentsply Sirona, Inc.
29 Sep 2023K2332573M™ Clarity™Aligners with Quick Attachments3M Company, Unitek Orthodontic Products
26 Sep 2023K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksAlign Technology, Inc.
1 Sep 2023K231884TRIOCLEAR SystemModern Dental Laboratory Co., Ltd.
13 Jun 2023K223517Clear AlignerWuxi EA Medical Instruments Technologies Limited
22 May 2023K2314643M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)3M Company, Unitek Orthodontic Products
24 Apr 2023K223141STR8 Clear AlignerStr8 Oral Care
17 Apr 2023K223454Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co.,Ltd
5 Apr 2023K221537Nightwear AlignersSmylio
16 Mar 2023K222619EnsmileEnsmile Pvt, Ltd.
24 Feb 2023K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GBlue Sky Bio, LLC
9 Feb 2023K223338Toothsi, SmilealignersMakeo Healthcare Technologies Private Limited
22 Dec 2022K222894Invisalign System, Pre-Formed Attachment SystemAlign Technology, Inc.
20 Dec 2022K222308Al Smile AlignerNanjing Jiahe Dental Technology Co., Ltd.
25 Nov 2022K222918DentCare AlignersDentcare Dental Lab Pvt , Ltd.
3 Nov 2022K223355Tera Harz ClearGraphy, Inc.
13 Oct 2022K211427CREOKORREKT AlignersCreoDent Prosthetics LTD
7 Oct 2022K222418NuvolaGruppo Europeo Ortodonzia Srl
5 Oct 2022K220140ClearCorrect SystemInstitut Straumann AG
31 Aug 2022K221475MyClearALIGN Dental Aligner SystemKey Dental Technologies, LLC
16 Aug 2022K213026Clear AlignerShenzhen Meiming Dentistry Technology Co., Ltd.
12 Aug 2022K220835ArklignersArklign Laboratories
14 Jul 2022K221097SmileSeriesOrdont Orthodontic Laboratories, Inc.
16 Jun 2022K203624Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co.,Ltd
31 May 2022K212680LuxCreo Clear Aligner SystemLuxCreo Inc.
23 May 2022K212803DailyMate Orthodontic Aligner System3D Global Biotech, Inc.
7 Apr 2022K220287Invisalign SystemAlign Technology, Inc.
16 Mar 2022K220726K ClearKline Europe GmbH
24 Feb 2022K211510uLab Systems Dental Aligner KituLab Systems, Inc.
9 Feb 2022K213297RedlineJohns Dental Laboratories
15 Jan 2022K212772Precision AlignPrecision Align, LLC
4 Nov 2021K212496Ortho Aligner SystemOrtho Lab Services, LLC
26 Oct 2021K211537QuickAlignersOral Image, Inc.
8 Oct 2021K203688Clear AlignerWuxi EA Medical Instruments Technologies Limited
29 Sep 2021K210763Inman Digital Clear AlignersInman Orthodontic Laboratories, Inc.
22 Sep 2021K212660Smylio Invisible Clear AlignersSmylio
20 Sep 2021K212961SMILERSBiotech Dental Smilers, SAS
27 Aug 2021K210373Clear AlignersShenzhen Yinuo Dental Technology Co.Ltd
6 Aug 2021K210320ClearCorrect SystemInstitut Straumann AG
6 Jul 2021K193622TRIOCLEAR SystemPerfection Aligner System Hong Kong Limited
4 Jun 2021K210613HIT Clear AlignerCdb Corporation
2 Jun 2021K2106526MS Invisible AlignerSms Opco, LLC
19 May 2021K210540Ohlendorf Clear AlignerOhlendorf Appliance Laboratory
26 Apr 2021K211010Illusion AlignersLaxmi Dental Exports Pvt, Ltd.
23 Apr 2021K2111903M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)3M Company, Unitek Orthodontic Products
22 Mar 2021K203737Spark Clear Aligner SystemSybron Dental Specialties
26 Feb 2021K201104AsoAlignerASO International Manila, Inc.
26 Feb 2021K173738ArchworxUtah Medical Products and Services
22 Jan 2021K202792BRIUS Clear AlignersBrius
6 Jan 2021K203339NEOLab Clear AlignersNew England Ortho Lab, Inc.
5 Jan 2021K202857ClearPath AlignerClearpath Orthodontics
22 Dec 2020K200908iSMILE3D Diagnostix inc
12 Nov 2020K193385TP Orthodontics Clear Aligner SystemTp Orthodontics, Inc.
9 Nov 2020K200005Concinnity AlignersDrake Precision Dental Laboratory, Inc.
28 Sep 2020K202685Eon AlignerEon Dental Jordan, LLC
10 Sep 2020K201450Straight T Clear Dental AlignerStraight T, Inc.
7 Aug 2020K193130MVP Aligner SystemMvp Aligners, LLC
11 May 2020K192244Arcad SmileStudio and Aligner SystemArcadlab
6 May 2020K192069Aerodentis SystemDror Orthodesign , Ltd.
23 Apr 2020K191308U-AlignerUniversal Orthodontic Laboratory, Inc.
20 Mar 2020K191838Clearform AlignersMotor City Lab Works
12 Mar 2020K192338NEOLab Clear AlignersNew England Ortho Lab, Inc.
24 Feb 2020K2002143D Predict3D Smile USA, Inc.
11 Feb 2020K192596ULab Systems Dental Aligner KituLab Systems, Inc.
10 Feb 2020K192846Argen Clear Aligner, Argen Clear Aligner PremiumThe Argen Corporation
29 Jan 2020K191837UniSmile Clear Aligner SystemVitang Technology LLC
8 Jan 2020K192767Clear AlignerRoyal Dental Laboratory
20 Dec 2019K192470DenMat Orthodontic AlignersDen-Mat Holdings, LLC
20 Dec 2019K191823Clear-AlignersCdb Corporation
19 Dec 2019K182388Krystal Klear AlignersShatkin F.I.R.S.T., LLC
16 Dec 2019K190394SunClear Aligner systemSun Dental Laboratories, LLC
6 Nov 2019K190003Vivid AlignersOrthodent Laboratory, Inc.
30 Sep 2019K191774SmileAlign Orthodontic Aligner System3D Global Biotech, Inc.
5 Sep 2019K1921193M Clarity Aligners3M Company
23 Aug 2019K191990OSW Aligner SystemOsw Manufacturing, LLC
27 Jun 2019K190583DynaFlexDyna Flex
19 Jun 2019K182658BiolinerFive Star Orthodontic Lab & Supply
7 Jun 2019K183229Argen Clear AlignerThe Argen Corporation
9 May 2019K190948Magic Clear AlignersVoodoo Manufacturing, Inc.
18 Apr 2019K181747Orthodontic ApplianceShandong Huge Dental Material Corporation
19 Feb 2019K180346Byte Aligner SystemStraight Smile, LLC
8 Jan 2019K180648Park Dental Research AlignersPark Dental Research Corp
3 Jan 2019K183643Clear Image AlignersSpecialty Appliance Works, Inc.
26 Nov 2018K1831593M Clarity Aligners3M Company
8 Nov 2018K182329SureCure Orthodontic Aligner SystemDigital Orthodontic Care
26 Oct 2018K181739Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc.
11 Oct 2018K182826Ormco Spark Aligner SystemSybron Dental Specialties
28 Sep 2018K180241Orthocaps TwinalignerOrtho Caps GmbH
23 Aug 2018K173784Smylic Invisible Clear AlignersSmylio
1 Jun 2018K172765Smart Moves CompleteGreat Lakes Orthodontics, Ltd.
13 Mar 2018K173785Custom Clear Aligner SystemDerby Dental Laboratory
9 Feb 2018K180107Blue Sky Bio AlignerBlue Sky Bio, LLC
19 Jan 2018K171674Angel Align SystemSmile Development Corp
5 Jan 2018K171860Sureclear alignersEmergo Global Consulting, LLC
6 Jul 2017K162609ClearPath AlignerClearpath Orthodontics
3 Feb 2017K163155MTM Clear AlignerDentsply Sirona, Inc.
27 Jan 2017K1636893M Clear Tray Aligner3M Unitek Corporation
11 Mar 2016K151965Dentti SystemMartz, Inc.
18 Nov 2015K143630Invisalign SystemAlign Technology, Inc.
9 Oct 2015K143499eClignerEclear International Co., Ltd.
1 Nov 2013K123514CLEARPATH ALIGNERQserve America, Inc.
11 Oct 2013K132145MTM(R) CLEAR ALIGNERDentsply International, Inc.
24 May 2013K123925MTM CLEAR ALIGNER IN-OFFICEDentsply International, Inc.
5 Apr 2013K130237PONTIC PAINTReliance Orthodontic Products, Inc.
14 Aug 2012K121396DYNAFLEXDyna Flex
19 Mar 2012K113618CLEARCORRECT SYSTEMInstitut Straumann AG
27 Aug 2010K093821FS ALIGNERSybron Dental Specialties
12 Feb 2009K073121NUBRACE INVISIBLE REMOVABLE ORTHODONTICSNubrace, Inc.
6 Feb 2009K082556CLEARCORRECTInstitut Straumann AG
17 Dec 2008K081960INVISALIGN SYSTEMAlign Technology, Inc.
11 Apr 2008K080246COMPOSITE ALIGNER BUTTONDentsply Interntional
25 Sep 2007K071970CLEAR IMAGE ALIGNERSpecialty Appliance Works, Inc.
18 Jun 2004K040874RED, WHITE & BLUESybron Dental Specialties
8 Sep 1998K981095ALIGN SYSTEMAlign Technology, Inc.

Official records: FDA product classification for NXC · 21 CFR 872.5470.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026