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)
Top companies in NXC
| Company | 510(k)s | Recalls |
|---|---|---|
| Align Technology | 12 | 0 |
| Clearcorrect, Inc. | 4 | 0 |
| Smylio, Inc. | 4 | 0 |
| 3M Company, Unitek Orthodontic Products | 3 | 0 |
| Blue Sky Bio, LLC | 3 | 0 |
| Dentsply Sirona | 3 | 0 |
| Ormco Corporation | 3 | 0 |
| 3D Global Biotech, Inc. | 2 | 0 |
| 3M Company | 2 | 0 |
| Allesee Orthodontic Appliances | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2019 | K182388 | Krystal Klear Aligners Shatkin F.I.R.S.T., LLC | NXC |
| Dec 16, 2019 | K190394 | SunClear Aligner system Sun Dental Laboratories, LLC | NXC |
| Nov 6, 2019 | K190003 | Vivid Aligners Orthodent Laboratory, Inc. | NXC |
| Sep 30, 2019 | K191774 | SmileAlign Orthodontic Aligner System 3D Global Biotech, Inc., TW | NXC |
| Sep 5, 2019 | K192119 | 3M Clarity Aligners 3M Company | NXC |
| Aug 23, 2019 | K191990 | OSW Aligner System Osw Manufacturing, LLC | NXC |
| Jun 27, 2019 | K190583 | DynaFlex Dyna Flex | NXC |
| Jun 19, 2019 | K182658 | Bioliner Five Star Orthodontic Lab & Supply | NXC |
| Jun 7, 2019 | K183229 | Argen Clear Aligner Argen Corporation | NXC |
| May 9, 2019 | K190948 | Magic Clear Aligners Voodoo Manufacturing, Inc. | NXC |
| Apr 18, 2019 | K181747 | Orthodontic Appliance Shandong Huge Dental Material Corporation, CN | NXC |
| Feb 19, 2019 | K180346 | Byte Aligner System Straight Smile, LLC | NXC |
| Jan 8, 2019 | K180648 | Park Dental Research Aligners Park Dental Research Corporation | NXC |
| Jan 3, 2019 | K183643 | Clear Image Aligners Specialty Appliance Works, Inc. | NXC |
| Nov 26, 2018 | K183159 | 3M Clarity Aligners 3M Company | NXC |
| Nov 8, 2018 | K182329 | SureCure Orthodontic Aligner System Digital Orthodontic Care, CA | NXC |
| Oct 26, 2018 | K181739 | Invisalign System with Mandibular Advancement Feature Align Technology, Inc. | NXC |
| Oct 11, 2018 | K182826 | Ormco Spark Aligner System Sybron Dental Specialties | NXC |
| Sep 28, 2018 | K180241 | Orthocaps Twinaligner Ortho Caps GmbH, DE | NXC |
| Aug 23, 2018 | K173784 | Smylic Invisible Clear Aligners Smylio, Inc. | NXC |
| Jun 1, 2018 | K172765 | Smart Moves Complete Great Lakes Orthodontics, Ltd. | NXC |
| Mar 13, 2018 | K173785 | Custom Clear Aligner System Derby Dental Laboratory | NXC |
| Feb 9, 2018 | K180107 | Blue Sky Bio Aligner Blue Sky Bio, LLC | NXC |
| Jan 19, 2018 | K171674 | Angel Align System Smile Development Corp | NXC |
| Jan 5, 2018 | K171860 | Sureclear aligners Emergo Global Consulting, LLC | NXC |
| Jul 6, 2017 | K162609 | ClearPath Aligner Clearpath Orthodontics, Ltd., PK | NXC |
| Feb 3, 2017 | K163155 | MTM Clear Aligner Dentsply Sirona | NXC |
| Jan 27, 2017 | K163689 | 3M Clear Tray Aligner 3M Unitek Corporation | NXC |
| Mar 11, 2016 | K151965 | Dentti System Martz, Inc. | NXC |
| Nov 18, 2015 | K143630 | Invisalign System Align Technology, Inc. | NXC |
| Oct 9, 2015 | K143499 | eCligner Eclear International Co., Ltd., KR | NXC |
| Nov 1, 2013 | K123514 | CLEARPATH ALIGNER Qserve America, Inc. | NXC |
| Oct 11, 2013 | K132145 | MTM(R) CLEAR ALIGNER Dentsply International, Inc. | NXC |
| May 24, 2013 | K123925 | MTM CLEAR ALIGNER IN-OFFICE Dentsply International, Inc. | NXC |
| Apr 5, 2013 | K130237 | PONTIC PAINT Reliance Orthodontic Products, Inc. | NXC |
| Aug 14, 2012 | K121396 | DYNAFLEX Dyna Flex | NXC |
| Mar 19, 2012 | K113618 | CLEARCORRECT SYSTEM Clearcorrect, Inc. | NXC |
| Aug 27, 2010 | K093821 | FS ALIGNER Allesee Orthodontic Appliances | NXC |
| Feb 12, 2009 | K073121 | NUBRACE INVISIBLE REMOVABLE ORTHODONTICS Nubrace, Inc. | NXC |
| Feb 6, 2009 | K082556 | CLEARCORRECT Clearcorrect, Inc. | NXC |
| Dec 17, 2008 | K081960 | INVISALIGN SYSTEM Align Technology | NXC |
| Apr 11, 2008 | K080246 | COMPOSITE ALIGNER BUTTON Dentsply Interntional | NXC |
| Sep 25, 2007 | K071970 | CLEAR IMAGE ALIGNER Specialty Appliance Works, Inc. | NXC |
| Jun 18, 2004 | K040874 | RED, WHITE & BLUE Allesee Orthodontic Appliances | NXC |
| Sep 8, 1998 | K981095 | ALIGN SYSTEM Align Technology | NXC |
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