Product Code: NXC FDA class 2 21 CFR 872.5470

Aligner, Sequential

Dental

The Sequential Aligner (product code NXC) is a dental device used to move teeth by applying continuous gentle force, intended for the orthodontic treatment of minor tooth malocclusion. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 872.5470 within the Dental specialty. Third-party 510(k) review is available, and the device carries no implant or life-sustaining flags.

View on FDA

510(k)s

144

FEI Numbers

Registration Numbers

Unique Applicants

105

Years Active

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Basic Information

Product Code: NXC
Device Class: FDA class 2
Regulation Number: 872.5470
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 144 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260788	Smylio Aligners	May 08, 2026	Substantially Equivalent	Smylio, Inc.
K260722	SureSmile Aligner (ASSY500020)	Apr 15, 2026	Substantially Equivalent	Dentsply Sirona, Inc.
K253282	ZSmile System	Feb 03, 2026	Substantially Equivalent	Dror Orthodesign , Ltd.
K251454	Clear Aligner (SCF-3348)	Jan 07, 2026	Substantially Equivalent	Beame Medical Technology (Shenzhen) Limited
K250739	Primeprint Direct Aligner	Nov 07, 2025	Substantially Equivalent	Dreve Dentamid GmbH
K252931	Invisalign® Palatal Expander System	Oct 23, 2025	Substantially Equivalent	Align Technology, Inc.
K252870	Invisalign Specifix Attachment System	Oct 09, 2025	Substantially Equivalent	Align Technology, Inc.
K251758	Serafin®	Sep 11, 2025	Substantially Equivalent	Tns Co., Ltd.
K252380	Invisalign System	Aug 29, 2025	Substantially Equivalent	Align Technology, Inc.
K251415	Additively Manufactured Aligner Resin	Aug 27, 2025	Substantially Equivalent	Aidite (Qinhuangdao) Technology Co., Ltd.
K251616	Clear Miracle	Jul 22, 2025	Substantially Equivalent	Ods Co., Ltd.
K242637	MEM Clear Aligner System	May 21, 2025	Substantially Equivalent	Mem Dental Technology Co., Ltd.
K250343	LuxCreo Clear Aligner System	Apr 08, 2025	Substantially Equivalent	LuxCreo, Inc.
K250487	SparkTM Clear Aligner System	Feb 20, 2025	Substantially Equivalent	Ormco Corporation
K242715	Pearl Clear Aligner	Jan 16, 2025	Substantially Equivalent	Pearl Digital, Inc.
K242929	Fas Aligner System	Dec 20, 2024	Substantially Equivalent	Xplora 3D Europe S.L
K242892	Cristaline Aligners Z FLX	Dec 19, 2024	Substantially Equivalent	Cristaline Aligners GmbH
K233152	GENIOVA aligners	Dec 12, 2024	Substantially Equivalent	Geniova Technologies Sociedad Limitada
K240501	Spark Clear Aligner System	Oct 11, 2024	Substantially Equivalent	Ormco Corporation
K233356	Illusion Aligner Pro: Illusion Aligner FLX	Aug 08, 2024	Substantially Equivalent	Laxmi Dental Export Pvt., Ltd.
K241137	Clear Moves Aligner	Aug 01, 2024	Substantially Equivalent	Clear Moves Aligners
K241187	Alien Aligners	Jul 26, 2024	Substantially Equivalent	Alien Milling Technologies
K241412	Invisalign System	Jun 18, 2024	Substantially Equivalent	Align Technology, Inc.
K233935	DigiLine Direct Print Aligner System	Apr 05, 2024	Substantially Equivalent	Park Dental Research Corporation
K240038	Clear Moves Aligners	Apr 04, 2024	Substantially Equivalent	Space Maintainers Laboratories (Sml)
K232653	Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX	Apr 03, 2024	Substantially Equivalent	Blue Sky Bio, LLC
K240597	TERA HARZ CLEAR	Mar 05, 2024	Substantially Equivalent	Graphy, Inc.
K233544	MESHEET	Feb 22, 2024	Substantially Equivalent	Dentis Co., Ltd.
K232074	Serafin®	Feb 22, 2024	Substantially Equivalent	Tns Co., Ltd.
K232887	Invisalign Palatal Expander System	Dec 15, 2023	Substantially Equivalent	Align Technology, Inc.
K230199	Byte Aligner System	Oct 18, 2023	Substantially Equivalent	Dentsply Sirona, Inc.
K233257	3M ClarityAligners with Quick Attachments	Sep 29, 2023	Substantially Equivalent	3M Company, Unitek Orthodontic Products
K232233	Invisalign System with Mandibular Advancement Featuring Occlusal Blocks	Sep 26, 2023	Substantially Equivalent	Align Technology, Inc.
K231884	TRIOCLEAR System	Sep 01, 2023	Substantially Equivalent	Modern Dental Laboratory (Dg) Co., Ltd.
K223517	Clear Aligner	Jun 13, 2023	Substantially Equivalent	Wuxi EA Medical Instruments Technologies Limited.
K231464	3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)	May 22, 2023	Substantially Equivalent	3M Company, Unitek Orthodontic Products
K223141	STR8 Clear Aligner	Apr 24, 2023	Substantially Equivalent	Str8 Oral Care
K223454	Custom-made Invisible Aligners	Apr 17, 2023	Substantially Equivalent	Zhejiang Yinchili Medical Technology Co., Ltd.
K221537	Nightwear Aligners	Apr 05, 2023	Substantially Equivalent	Smylio, Inc.
K222619	Ensmile	Mar 16, 2023	Substantially Equivalent	Ensmile Pvt, Ltd.
K221845	Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G	Feb 24, 2023	Substantially Equivalent	Blue Sky Bio, LLC
K223338	Toothsi, Smilealigners	Feb 09, 2023	Substantially Equivalent	Makeo Healthcare Technologies Private Limited
K222894	Invisalign System, Pre-Formed Attachment System	Dec 22, 2022	Substantially Equivalent	Align Technology, Inc.
K222308	Al Smile Aligner	Dec 20, 2022	Substantially Equivalent	Nanjing Jiahe Dental Technology Co., Ltd.
K222918	DentCare Aligners	Nov 25, 2022	Substantially Equivalent	Dentcare Dental Lab Pvt , Ltd.
K223355	Tera Harz Clear	Nov 03, 2022	Substantially Equivalent	Graphy, Inc.
K211427	CREOKORREKT Aligners	Oct 13, 2022	Substantially Equivalent	Creodent Prosthetics, Ltd.
K222418	Nuvola	Oct 07, 2022	Substantially Equivalent	Gruppo Europeo Ortodonzia Srl
K220140	ClearCorrect System	Oct 05, 2022	Substantially Equivalent	Clearcorrect, LLC
K221475	MyClearALIGN Dental Aligner System	Aug 31, 2022	Substantially Equivalent	Key Dental Technologies, LLC
K213026	Clear Aligner	Aug 16, 2022	Substantially Equivalent	Shenzhen Meiming Dentistry Technology Co., Ltd.
K220835	Arkligners	Aug 12, 2022	Substantially Equivalent	Arklign Laboratories
K221097	SmileSeries	Jul 14, 2022	Substantially Equivalent	Ordont Orthodontic Laboratories, Inc.
K203624	Custom-made Invisible Aligners	Jun 16, 2022	Substantially Equivalent	Zhejiang Yinchili Medical Technology Co., Ltd.
K212680	LuxCreo Clear Aligner System	May 31, 2022	Substantially Equivalent	LuxCreo, Inc.
K212803	DailyMate Orthodontic Aligner System	May 23, 2022	Substantially Equivalent	3D Global Biotech, Inc.
K220287	Invisalign System	Apr 07, 2022	Substantially Equivalent	Align Technology, Inc.
K220726	K Clear	Mar 16, 2022	Substantially Equivalent	Kline Europe GmbH
K211510	uLab Systems Dental Aligner Kit	Feb 24, 2022	Substantially Equivalent	Ulab Systems, Inc.
K213297	Redline	Feb 09, 2022	Substantially Equivalent	Johns Dental Laboratories
K212772	Precision Align	Jan 15, 2022	Substantially Equivalent	Precision Align, LLC
K212496	Ortho Aligner System	Nov 04, 2021	Substantially Equivalent	Ortho Lab Services, LLC
K211537	QuickAligners	Oct 26, 2021	Substantially Equivalent	Oral Image, Inc.
K203688	Clear Aligner	Oct 08, 2021	Substantially Equivalent	Wuxi EA Medical Instruments Technologies Limited.
K210763	Inman Digital Clear Aligners	Sep 29, 2021	Substantially Equivalent	Inman Orthodontic Laboratories, Inc.
K212660	Smylio Invisible Clear Aligners	Sep 22, 2021	Substantially Equivalent	Smylio, Inc.
K212961	SMILERS	Sep 20, 2021	Substantially Equivalent	Biotech Dental Smilers, Sas
K210373	Clear Aligners	Aug 27, 2021	Substantially Equivalent	Shenzhen Yinuo Dental Technology Co.Ltd
K210320	ClearCorrect System	Aug 06, 2021	Substantially Equivalent	Clearcorrect, LLC
K193622	TRIOCLEAR System	Jul 06, 2021	Substantially Equivalent	Perfection Aligner System Hong Kong Limited
K210613	HIT Clear Aligner	Jun 04, 2021	Substantially Equivalent	Cdb Corporation
K210652	6MS Invisible Aligner	Jun 02, 2021	Substantially Equivalent	Sms Opco, LLC
K210540	Ohlendorf Clear Aligner	May 19, 2021	Substantially Equivalent	Ohlendorf Appliance Laboratory
K211010	Illusion Aligners	Apr 26, 2021	Substantially Equivalent	Laxmi Dental Exports Pvt, Ltd.
K211190	3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)	Apr 23, 2021	Substantially Equivalent	3M Company, Unitek Orthodontic Products
K203737	Spark Clear Aligner System	Mar 22, 2021	Substantially Equivalent	Ormco Corporation
K201104	AsoAligner	Feb 26, 2021	Substantially Equivalent	Aso International Manila, Inc.
K173738	Archworx	Feb 26, 2021	Substantially Equivalent	Utah Medical Products and Services
K202792	BRIUS Clear Aligners	Jan 22, 2021	Substantially Equivalent	Brius Technologies, Inc.
K203339	NEOLab Clear Aligners	Jan 06, 2021	Substantially Equivalent	New England Ortho Lab, Inc.
K202857	ClearPath Aligner	Jan 05, 2021	Substantially Equivalent	Clearpath Orthodontics, Ltd.
K200908	iSMILE	Dec 22, 2020	Substantially Equivalent	3D Diagnostix, Inc.
K193385	TP Orthodontics Clear Aligner System	Nov 12, 2020	Substantially Equivalent	Tp Orthodontics, Inc.
K200005	Concinnity Aligners	Nov 09, 2020	Substantially Equivalent	Drake Precision Dental Laboratory, Inc.
K202685	Eon Aligner	Sep 28, 2020	Substantially Equivalent	Eon Dental Jordan, LLC
K201450	Straight T Clear Dental Aligner	Sep 10, 2020	Substantially Equivalent	Straight T, Inc.
K193130	MVP Aligner System	Aug 07, 2020	Substantially Equivalent	Mvp Aligners, LLC
K192244	Arcad SmileStudio and Aligner System	May 11, 2020	Substantially Equivalent	Arcadlab
K192069	Aerodentis System	May 06, 2020	Substantially Equivalent	Dror Orthodesign
K191308	U-Aligner	Apr 23, 2020	Substantially Equivalent	Universal Orthodontic Laboratory, Inc.
K191838	Clearform Aligners	Mar 20, 2020	Substantially Equivalent	Motor City Lab Works
K192338	NEOLab Clear Aligners	Mar 12, 2020	Substantially Equivalent	New England Ortho Lab, Inc.
K200214	3D Predict	Feb 24, 2020	Substantially Equivalent	3D Smile USA, Inc.
K192596	ULab Systems Dental Aligner Kit	Feb 11, 2020	Substantially Equivalent	Ulab Systems, Inc.
K192846	Argen Clear Aligner, Argen Clear Aligner Premium	Feb 10, 2020	Substantially Equivalent	Argen Corporation
K191837	UniSmile Clear Aligner System	Jan 29, 2020	Substantially Equivalent	Vitang Technology, LLC
K192767	Clear Aligner	Jan 08, 2020	Substantially Equivalent	Royal Dental Lab
K192470	DenMat Orthodontic Aligners	Dec 20, 2019	Substantially Equivalent	Denmat Holdings, LLC
K191823	Clear-Aligners	Dec 20, 2019	Substantially Equivalent	Cdb Corporation
K182388	Krystal Klear Aligners	Dec 19, 2019	Substantially Equivalent	Shatkin F.I.R.S.T., LLC
K190394	SunClear Aligner system	Dec 16, 2019	Substantially Equivalent	Sun Dental Laboratories, LLC
K190003	Vivid Aligners	Nov 06, 2019	Substantially Equivalent	Orthodent Laboratory, Inc.
K191774	SmileAlign Orthodontic Aligner System	Sep 30, 2019	Substantially Equivalent	3D Global Biotech, Inc.
K192119	3M Clarity Aligners	Sep 05, 2019	Substantially Equivalent	3M Company
K191990	OSW Aligner System	Aug 23, 2019	Substantially Equivalent	Osw Manufacturing, LLC
K190583	DynaFlex	Jun 27, 2019	Substantially Equivalent	Dyna Flex
K182658	Bioliner	Jun 19, 2019	Substantially Equivalent	Five Star Orthodontic Lab & Supply
K183229	Argen Clear Aligner	Jun 07, 2019	Substantially Equivalent	Argen Corporation
K190948	Magic Clear Aligners	May 09, 2019	Substantially Equivalent	Voodoo Manufacturing, Inc.
K181747	Orthodontic Appliance	Apr 18, 2019	Substantially Equivalent	Shandong Huge Dental Material Corporation
K180346	Byte Aligner System	Feb 19, 2019	Substantially Equivalent	Straight Smile, LLC
K180648	Park Dental Research Aligners	Jan 08, 2019	Substantially Equivalent	Park Dental Research Corporation
K183643	Clear Image Aligners	Jan 03, 2019	Substantially Equivalent	Specialty Appliance Works, Inc.
K183159	3M Clarity Aligners	Nov 26, 2018	Substantially Equivalent	3M Company
K182329	SureCure Orthodontic Aligner System	Nov 08, 2018	Substantially Equivalent	Digital Orthodontic Care
K181739	Invisalign System with Mandibular Advancement Feature	Oct 26, 2018	Substantially Equivalent	Align Technology, Inc.
K182826	Ormco Spark Aligner System	Oct 11, 2018	Substantially Equivalent	Sybron Dental Specialties
K180241	Orthocaps Twinaligner	Sep 28, 2018	Substantially Equivalent	Ortho Caps GmbH
K173784	Smylic Invisible Clear Aligners	Aug 23, 2018	Substantially Equivalent	Smylio, Inc.
K172765	Smart Moves Complete	Jun 01, 2018	Substantially Equivalent	Great Lakes Orthodontics, Ltd.
K173785	Custom Clear Aligner System	Mar 13, 2018	Substantially Equivalent	Derby Dental Laboratory
K180107	Blue Sky Bio Aligner	Feb 09, 2018	Substantially Equivalent	Blue Sky Bio, LLC
K171674	Angel Align System	Jan 19, 2018	Substantially Equivalent	Smile Development Corp
K171860	Sureclear aligners	Jan 05, 2018	Substantially Equivalent	Emergo Global Consulting, LLC
K162609	ClearPath Aligner	Jul 06, 2017	Substantially Equivalent	Clearpath Orthodontics, Ltd.
K163155	MTM Clear Aligner	Feb 03, 2017	Substantially Equivalent	Dentsply Sirona
K163689	3M Clear Tray Aligner	Jan 27, 2017	Substantially Equivalent	3M Unitek Corporation
K151965	Dentti System	Mar 11, 2016	Substantially Equivalent	Martz, Inc.
K143630	Invisalign System	Nov 18, 2015	Substantially Equivalent	Align Technology, Inc.
K143499	eCligner	Oct 09, 2015	Substantially Equivalent	Eclear International Co., Ltd.
K123514	CLEARPATH ALIGNER	Nov 01, 2013	Substantially Equivalent	Qserve America, Inc.
K132145	MTM(R) CLEAR ALIGNER	Oct 11, 2013	Substantially Equivalent	Dentsply International, Inc.
K123925	MTM CLEAR ALIGNER IN-OFFICE	May 24, 2013	Substantially Equivalent	Dentsply International, Inc.
K130237	PONTIC PAINT	Apr 05, 2013	Substantially Equivalent	Reliance Orthodontic Products, Inc.
K121396	DYNAFLEX	Aug 14, 2012	Substantially Equivalent	Dyna Flex
K113618	CLEARCORRECT SYSTEM	Mar 19, 2012	Substantially Equivalent	Clearcorrect, Inc.
K093821	FS ALIGNER	Aug 27, 2010	Substantially Equivalent	Allesee Orthodontic Appliances
K073121	NUBRACE INVISIBLE REMOVABLE ORTHODONTICS	Feb 12, 2009	Substantially Equivalent	Nubrace, Inc.
K082556	CLEARCORRECT	Feb 06, 2009	Substantially Equivalent	Clearcorrect, Inc.
K081960	INVISALIGN SYSTEM	Dec 17, 2008	Substantially Equivalent	Align Technology
K080246	COMPOSITE ALIGNER BUTTON	Apr 11, 2008	Substantially Equivalent	Dentsply Interntional
K071970	CLEAR IMAGE ALIGNER	Sep 25, 2007	Substantially Equivalent	Specialty Appliance Works, Inc.
K040874	RED, WHITE & BLUE	Jun 18, 2004	Substantially Equivalent	Allesee Orthodontic Appliances
K981095	ALIGN SYSTEM	Sep 08, 1998	Substantially Equivalent	Align Technology