FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K200908 |
3D Diagnostix Inc. |
iSMILE |
12/22/2020 |
K212803 |
3D Global Biotech Inc |
DailyMate Orthodontic Aligner System |
05/23/2022 |
K191774 |
3D Global Biotech Inc. |
SmileAlign Orthodontic Aligner System |
09/30/2019 |
K200214 |
3D Smile USA, Inc |
3D Predict |
02/24/2020 |
K183159 |
3M Company |
3M Clarity Aligners |
11/26/2018 |
K192119 |
3M Company |
3M Clarity Aligners |
09/05/2019 |
K211190 |
3M Company, Unitek Orthodontic Products |
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) |
04/23/2021 |
K231464 |
3M Company, Unitek Orthodontic Products |
3MÖ ClarityÖ Aligners (3MÖ ClarityÖ Aligners-Force, 3MÖ ClarityÖ Aligners-Flex) |
05/22/2023 |
K233257 |
3M Company, Unitek Orthodontic Products |
3MÖ ClarityÖAligners with Quick Attachments |
09/29/2023 |
K163689 |
3M Unitek Corporation |
3M Clear Tray Aligner |
01/27/2017 |
K981095 |
ALIGN TECHNOLOGY |
ALIGN SYSTEM |
09/08/1998 |
K081960 |
ALIGN TECHNOLOGY |
INVISALIGN SYSTEM |
12/17/2008 |
K143630 |
ALIGN TECHNOLOGY, INC. |
Invisalign System |
11/18/2015 |
K220287 |
Align Technology, Inc. |
Invisalign System |
04/07/2022 |
K181739 |
Align Technology, Inc. |
Invisalign System with Mandibular Advancement Feature |
10/26/2018 |
K232233 |
Align Technology, Inc. |
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks |
09/26/2023 |
K222894 |
Align Technology, Inc. |
Invisalign System, Pre-Formed Attachment System |
12/22/2022 |
K093821 |
ALLESEE ORTHODONTIC APPLIANCES |
FS ALIGNER |
08/27/2010 |
K040874 |
ALLESEE ORTHODONTIC APPLIANCES |
RED, WHITE & BLUE |
06/18/2004 |
K223338 |
AMPA Orthodontics Private Limited |
Toothsi, Smilealigners |
02/09/2023 |
K192244 |
ArcadLab |
Arcad SmileStudio and Aligner System |
05/11/2020 |
K183229 |
Argen Corporation |
Argen Clear Aligner |
06/07/2019 |
K192846 |
Argen Corporation |
Argen Clear Aligner, Argen Clear Aligner Premium |
02/10/2020 |
K220835 |
Arklign Laboratories |
Arkligners |
08/12/2022 |
K201104 |
Aso International Manila, Inc. |
AsoAligner |
02/26/2021 |
K212961 |
Biotech Dental Smilers, SAS |
SMILERS |
09/20/2021 |
K180107 |
Blue Sky Bio LLC |
Blue Sky Bio Aligner |
02/09/2018 |
K221845 |
Blue Sky Bio, LLC |
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G |
02/24/2023 |
K202792 |
Brius Technologies, Inc |
BRIUS Clear Aligners |
01/22/2021 |
K191823 |
CDB Corporation |
Clear-Aligners |
12/20/2019 |
K210613 |
CDB Corporation |
HIT Clear Aligner |
06/04/2021 |
K210320 |
ClearCorrect LLC |
ClearCorrect System |
08/06/2021 |
K082556 |
CLEARCORRECT, INC. |
CLEARCORRECT |
02/06/2009 |
K113618 |
CLEARCORRECT, INC. |
CLEARCORRECT SYSTEM |
03/19/2012 |
K220140 |
ClearCorrect, LLC |
ClearCorrect System |
10/05/2022 |
K162609 |
ClearPath Orthodontics Ltd |
ClearPath Aligner |
07/06/2017 |
K202857 |
ClearPath Orthodontics Ltd |
ClearPath Aligner |
01/05/2021 |
K211427 |
CreoDent Prosthetics LTD |
CREOKORREKT Aligners |
10/13/2022 |
K192470 |
DenMat Holdings, LLC |
DenMat Orthodontic Aligners |
12/20/2019 |
K222918 |
DentCare Dental Lab Pvt Ltd. |
DentCare Aligners |
11/25/2022 |
K123925 |
DENTSPLY INTERNATIONAL, INC. |
MTM CLEAR ALIGNER IN-OFFICE |
05/24/2013 |
K132145 |
DENTSPLY INTERNATIONAL, INC. |
MTM(R) CLEAR ALIGNER |
10/11/2013 |
K080246 |
DENTSPLY INTERNTIONAL |
COMPOSITE ALIGNER BUTTON |
04/11/2008 |
K163155 |
DENTSPLY SIRONA |
MTM Clear Aligner |
02/03/2017 |
K173785 |
Derby Dental Laboratory |
Custom Clear Aligner System |
03/13/2018 |
K182329 |
Digital Orthodontic Care |
SureCure Orthodontic Aligner System |
11/08/2018 |
K200005 |
Drake Precision Dental Laboratory Inc |
Concinnity Aligners |
11/09/2020 |
K192069 |
Dror Orthodesign |
Aerodentis System |
05/06/2020 |
K121396 |
DYNA FLEX |
DYNAFLEX |
08/14/2012 |
K190583 |
DynaFlex |
DynaFlex |
06/27/2019 |
K143499 |
eClear International Co., Ltd. |
eCligner |
10/09/2015 |
K171860 |
Emergo Global Consulting, LLC |
Sureclear aligners |
01/05/2018 |
K222619 |
Ensmile Pvt Ltd |
Ensmile |
03/16/2023 |
K202685 |
Eon Dental Jordan LLC |
Eon Aligner |
09/28/2020 |
K182658 |
Five Star Orthodontic Lab & Supply |
Bioliner |
06/19/2019 |
K223355 |
Graphy Inc. |
Tera Harz Clear |
11/03/2022 |
K172765 |
Great Lakes Orthodontics Ltd |
Smart Moves Complete |
06/01/2018 |
K222418 |
Gruppo Europeo Ortodonzia srl |
Nuvola |
10/07/2022 |
K210763 |
Inman Orthodontic Laboratories, Inc. |
Inman Digital Clear Aligners |
09/29/2021 |
K213297 |
Johns Dental Laboratories |
Redline |
02/09/2022 |
K220726 |
K Line Europe GmbH |
K Clear |
03/16/2022 |
K221475 |
Key Dental Technologies, LLC |
MyClearALIGN Dental Aligner System |
08/31/2022 |
K211010 |
Laxmi Dental Exports Pvt Ltd |
Illusion Aligners |
04/26/2021 |
K212680 |
Luxcreo Inc |
LuxCreo Clear Aligner System |
05/31/2022 |
K151965 |
Martz, Inc |
Dentti System |
03/11/2016 |
K231884 |
Modern Dental Laboratory (DG) Co., Ltd. |
TRIOCLEAR System |
09/01/2023 |
K191838 |
Motor City Lab Works |
Clearform Aligners |
03/20/2020 |
K193130 |
MVP Aligners, LLC |
MVP Aligner System |
08/07/2020 |
K222308 |
Nanjing Jiahe Dental Technology Co., Ltd. |
Al Smile Aligner |
12/20/2022 |
K203339 |
New England Ortho Lab, Inc |
NEOLab Clear Aligners |
01/06/2021 |
K192338 |
New England Ortho Lab, Inc. |
NEOLab Clear Aligners |
03/12/2020 |
K073121 |
NUBRACE, INC. |
NUBRACE INVISIBLE REMOVABLE ORTHODONTICS |
02/12/2009 |
K210540 |
Ohlendorf Appliance Laboratory |
Ohlendorf Clear Aligner |
05/19/2021 |
K211537 |
Oral Image, Inc |
QuickAligners |
10/26/2021 |
K221097 |
Ordont Orthodontic Laboratories, Inc. |
SmileSeries |
07/14/2022 |
K203737 |
Ormco Corporation |
Spark Clear Aligner System |
03/22/2021 |
K180241 |
Ortho Caps GmbH |
Orthocaps Twinaligner |
09/28/2018 |
K212496 |
Ortho Lab Services, LLC |
Ortho Aligner System |
11/04/2021 |
K190003 |
Orthodent Laboratory, Inc. |
Vivid Aligners |
11/06/2019 |
K191990 |
OSW Manufacturing, LLC |
OSW Aligner System |
08/23/2019 |
K180648 |
Park Dental Research Corporation |
Park Dental Research Aligners |
01/08/2019 |
K193622 |
Perfection Aligner System Hong Kong Limited |
TRIOCLEAR System |
07/06/2021 |
K212772 |
Precision Align LLC. |
Precision Align |
01/15/2022 |
K123514 |
QSERVE AMERICA, INC. |
CLEARPATH ALIGNER |
11/01/2013 |
K130237 |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
PONTIC PAINT |
04/05/2013 |
K192767 |
Royal Dental Lab |
Clear Aligner |
01/08/2020 |
K181747 |
Shandong Huge Dental Material Corporation |
Orthodontic Appliance |
04/18/2019 |
K182388 |
Shatkin F.I.R.S.T. LLC |
Krystal Klear Aligners |
12/19/2019 |
K213026 |
Shenzhen Meiming Dentistry Technology Co., Ltd |
Clear Aligner |
08/16/2022 |
K210373 |
Shenzhen Yinuo Dental Technology Co.LTD |
Clear Aligners |
08/27/2021 |
K171674 |
Smile Development Corp |
Angel Align System |
01/19/2018 |
K210652 |
SMS OPCO, LLC |
6MS Invisible Aligner |
06/02/2021 |
K221537 |
Smylio Inc. |
Nightwear Aligners |
04/05/2023 |
K173784 |
Smylio, Inc |
Smylic Invisible Clear Aligners |
08/23/2018 |
K212660 |
Smylio, Inc |
Smylio Invisible Clear Aligners |
09/22/2021 |
K071970 |
SPECIALTY APPLIANCE WORKS, INC. |
CLEAR IMAGE ALIGNER |
09/25/2007 |
K183643 |
Specialty Appliance Works, Inc. |
Clear Image Aligners |
01/03/2019 |
K223141 |
STR8 Oral Care |
STR8 Clear Aligner |
04/24/2023 |
K180346 |
Straight Smile, LLC |
Byte Aligner System |
02/19/2019 |
K201450 |
Straight T, Inc. |
Straight T Clear Dental Aligner |
09/10/2020 |
K190394 |
Sun Dental Laboratories, LLC |
SunClear Aligner system |
12/16/2019 |
K182826 |
Sybron Dental Specialties |
Ormco Spark Aligner System |
10/11/2018 |
K193385 |
TP Orthodontics Inc. |
TP Orthodontics Clear Aligner System |
11/12/2020 |
K211510 |
uLab Systems, Inc. |
uLab Systems Dental Aligner Kit |
02/24/2022 |
K192596 |
uLab Systems, Inc. |
ULab Systems Dental Aligner Kit |
02/11/2020 |
K191308 |
Universal Orthodontic Laboratory Inc |
U-Aligner |
04/23/2020 |
K173738 |
Utah Medical Products and Services |
Archworx |
02/26/2021 |
K191837 |
Vitang Technology, LLC |
UniSmile Clear Aligner System |
01/29/2020 |
K190948 |
Voodoo Manufacturing, Inc. |
Magic Clear Aligners |
05/09/2019 |
K203688 |
Wuxi EA Medical Instruments Technologies Limited. |
Clear Aligner |
10/08/2021 |
K223517 |
Wuxi EA Medical Instruments Technologies Limited. |
Clear Aligner |
06/13/2023 |
K203624 |
Zhejiang Yinchili Medical Technology Co., Ltd. |
Custom-made Invisible Aligners |
06/16/2022 |
K223454 |
Zhejiang Yinchili Medical Technology Co., Ltd. |
Custom-made Invisible Aligners |
04/17/2023 |