NXC · Class II · 21 CFR 872.5470

FDA Product Code NXC: Aligner, Sequential

The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.

Leading manufacturers include Align Technology, Inc., Smylio, Inc. and Blue Sky Bio, LLC.

144
Total
144
Cleared
169d
Avg days
1998
Since
144 devices
49–72 of 144
Cleared Oct 05, 2022
ClearCorrect System
K220140
Clearcorrect, LLC
Dental · 260d
Cleared Aug 31, 2022
MyClearALIGN Dental Aligner System
K221475
Key Dental Technologies, LLC
Dental · 103d
Cleared Aug 16, 2022
Clear Aligner
K213026
Shenzhen Meiming Dentistry Technology Co., Ltd.
Dental · 329d
Cleared Aug 12, 2022
Arkligners
K220835
Arklign Laboratories
Dental · 143d
Cleared Jul 14, 2022
SmileSeries
K221097
Ordont Orthodontic Laboratories, Inc.
Dental · 91d
Cleared Jun 16, 2022
Custom-made Invisible Aligners
K203624
Zhejiang Yinchili Medical Technology Co., Ltd.
Dental · 552d
Cleared May 31, 2022
LuxCreo Clear Aligner System
K212680
LuxCreo, Inc.
Dental · 280d
Cleared May 23, 2022
DailyMate Orthodontic Aligner System
K212803
3D Global Biotech, Inc.
Dental · 263d
Cleared Apr 07, 2022
Invisalign System
K220287
Align Technology, Inc.
Dental · 65d
Cleared Mar 16, 2022
K Clear
K220726
Kline Europe GmbH
Dental · 2d
Cleared Feb 24, 2022
uLab Systems Dental Aligner Kit
K211510
Ulab Systems, Inc.
Dental · 286d
Cleared Feb 09, 2022
Redline
K213297
Johns Dental Laboratories
Dental · 131d
Cleared Jan 15, 2022
Precision Align
K212772
Precision Align, LLC
Dental · 137d
Cleared Nov 04, 2021
Ortho Aligner System
K212496
Ortho Lab Services, LLC
Dental · 87d
Cleared Oct 26, 2021
QuickAligners
K211537
Oral Image, Inc.
Dental · 161d
Cleared Oct 08, 2021
Clear Aligner
K203688
Wuxi EA Medical Instruments Technologies Limited.
Dental · 295d
Cleared Sep 29, 2021
Inman Digital Clear Aligners
K210763
Inman Orthodontic Laboratories, Inc.
Dental · 198d
Cleared Sep 22, 2021
Smylio Invisible Clear Aligners
K212660
Smylio, Inc.
Dental · 30d
Cleared Sep 20, 2021
SMILERS
K212961
Biotech Dental Smilers, Sas
Dental · 4d
Cleared Aug 27, 2021
Clear Aligners
K210373
Shenzhen Yinuo Dental Technology Co.Ltd
Dental · 200d
Cleared Aug 06, 2021
ClearCorrect System
K210320
Clearcorrect, LLC
Dental · 183d
Cleared Jul 06, 2021
TRIOCLEAR System
K193622
Perfection Aligner System Hong Kong Limited
Dental · 558d
Cleared Jun 04, 2021
HIT Clear Aligner
K210613
Cdb Corporation
Dental · 95d
Cleared Jun 02, 2021
6MS Invisible Aligner
K210652
Sms Opco, LLC
Dental · 90d