ClearanceBrief
Panels › Dental › Product code NXC · Class 2

Aligner, Sequential

Regulation 872.5470

6510(k)s in 12 months (145 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in NXC

Company510(k)sRecalls
Align Technology120
Clearcorrect, Inc.40
Smylio, Inc.40
3M Company, Unitek Orthodontic Products30
Blue Sky Bio, LLC30
Dentsply Sirona30
Ormco Corporation30
3D Global Biotech, Inc.20
3M Company20
Allesee Orthodontic Appliances20
Decided510(k)Device and applicantCode
Jul 2, 2026K260527FACE4D Aligner
Avinent Implant System S.L.U., ES
NXC
May 8, 2026K260788Smylio Aligners
Smylio, Inc.
NXC
Apr 15, 2026K260722SureSmile Aligner (ASSY500020)
Dentsply Sirona, Inc.
NXC
Feb 3, 2026K253282ZSmile System
Dror Orthodesign , Ltd., IL
NXC
Jan 7, 2026K251454Clear Aligner (SCF-3348)
Beame Medical Technology (Shenzhen) Limited, CN
NXC
Nov 7, 2025K250739Primeprint Direct Aligner
Dreve Dentamid GmbH, DE
NXC
Oct 23, 2025K252931Invisalign® Palatal Expander System
Align Technology, Inc.
NXC
Oct 9, 2025K252870Invisalign Specifix Attachment System
Align Technology, Inc.
NXC
Sep 11, 2025K251758Serafin®
Tns Co., Ltd., KR
NXC
Aug 29, 2025K252380Invisalign System
Align Technology, Inc.
NXC
Aug 27, 2025K251415Additively Manufactured Aligner Resin
Aidite (Qinhuangdao) Technology Co., Ltd., CN
NXC
Jul 22, 2025K251616Clear Miracle
Ods Co., Ltd., KR
NXC
May 21, 2025K242637MEM Clear Aligner System
Mem Dental Technology Co., Ltd., TW
NXC
Apr 8, 2025K250343LuxCreo Clear Aligner System
LuxCreo, Inc.
NXC
Feb 20, 2025K250487SparkTM Clear Aligner System
Ormco Corporation
NXC
Jan 16, 2025K242715Pearl Clear Aligner
Pearl Digital, Inc.
NXC
Dec 20, 2024K242929Fas Aligner System
Xplora 3D Europe S.L, ES
NXC
Dec 19, 2024K242892Cristaline Aligners Z FLX
Cristaline Aligners GmbH, DE
NXC
Dec 12, 2024K233152GENIOVA aligners
Geniova Technologies Sociedad Limitada, ES
NXC
Oct 11, 2024K240501Spark™ Clear Aligner System
Ormco Corporation
NXC
Aug 8, 2024K233356Illusion Aligner Pro: Illusion Aligner FLX
Laxmi Dental Export Pvt., Ltd., IN
NXC
Aug 1, 2024K241137Clear Moves Aligner
Clear Moves Aligners, PK
NXC
Jul 26, 2024K241187Alien Aligners
Alien Milling Technologies
NXC
Jun 18, 2024K241412Invisalign System
Align Technology, Inc.
NXC
Apr 5, 2024K233935DigiLine Direct Print Aligner System
Park Dental Research Corporation
NXC
Apr 4, 2024K240038Clear Moves Aligners
Space Maintainers Laboratories (Sml)
NXC
Apr 3, 2024K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
Blue Sky Bio, LLC
NXC
Mar 5, 2024K240597TERA HARZ CLEAR
Graphy, Inc., KR
NXC
Feb 22, 2024K233544MESHEET
Dentis Co., Ltd., KR
NXC
Feb 22, 2024K232074Serafin®
Tns Co., Ltd., KR
NXC
Dec 15, 2023K232887Invisalign Palatal Expander System
Align Technology, Inc.
NXC
Oct 18, 2023K230199Byte Aligner System
Dentsply Sirona, Inc.
NXC
Sep 29, 2023K2332573M™ Clarity™Aligners with Quick Attachments
3M Company, Unitek Orthodontic Products
NXC
Sep 26, 2023K232233Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
Align Technology, Inc.
NXC
Sep 1, 2023K231884TRIOCLEAR System
Modern Dental Laboratory (Dg) Co., Ltd., CN
NXC
Jun 13, 2023K223517Clear Aligner
Wuxi EA Medical Instruments Technologies Limited., CN
NXC
May 22, 2023K2314643M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
3M Company, Unitek Orthodontic Products
NXC
Apr 24, 2023K223141STR8 Clear Aligner
Str8 Oral Care
NXC
Apr 17, 2023K223454Custom-made Invisible Aligners
Zhejiang Yinchili Medical Technology Co., Ltd., CN
NXC
Apr 5, 2023K221537Nightwear Aligners
Smylio, Inc.
NXC
Mar 16, 2023K222619Ensmile
Ensmile Pvt, Ltd., PK
NXC
Feb 24, 2023K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
Blue Sky Bio, LLC
NXC
Feb 9, 2023K223338Toothsi, Smilealigners
Makeo Healthcare Technologies Private Limited, IN
NXC
Dec 22, 2022K222894Invisalign System, Pre-Formed Attachment System
Align Technology, Inc.
NXC
Dec 20, 2022K222308Al Smile Aligner
Nanjing Jiahe Dental Technology Co., Ltd., CN
NXC
Nov 25, 2022K222918DentCare Aligners
Dentcare Dental Lab Pvt , Ltd., IN
NXC
Nov 3, 2022K223355Tera Harz Clear
Graphy, Inc., KR
NXC
Oct 13, 2022K211427CREOKORREKT Aligners
Creodent Prosthetics, Ltd.
NXC
Oct 7, 2022K222418Nuvola
Gruppo Europeo Ortodonzia Srl, IT
NXC
Oct 5, 2022K220140ClearCorrect System
Clearcorrect, LLC
NXC

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