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 Ormco Corporation.

144
Total
144
Cleared
169d
Avg days
1998
Since
144 devices
25–48 of 144
Cleared Apr 04, 2024
Clear Moves Aligners
K240038
Space Maintainers Laboratories (Sml)
Dental · 90d
Cleared Apr 03, 2024
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
K232653
Blue Sky Bio, LLC
Dental · 216d
Cleared Mar 05, 2024
TERA HARZ CLEAR
K240597
Graphy, Inc.
Dental · 1d
Cleared Feb 22, 2024
Serafin®
K232074
Tns Co., Ltd.
Dental · 225d
Cleared Feb 22, 2024
MESHEET
K233544
Dentis Co., Ltd.
Dental · 111d
Cleared Dec 15, 2023
Invisalign Palatal Expander System
K232887
Align Technology, Inc.
Dental · 88d
Cleared Oct 18, 2023
Byte Aligner System
K230199
Dentsply Sirona, Inc.
Dental · 266d
Cleared Sep 29, 2023
3M™ Clarity™Aligners with Quick Attachments
K233257
3M Company, Unitek Orthodontic Products
Dental · 1d
Cleared Sep 26, 2023
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
K232233
Align Technology, Inc.
Dental · 61d
Cleared Sep 01, 2023
TRIOCLEAR System
K231884
Modern Dental Laboratory (Dg) Co., Ltd.
Dental · 66d
Cleared Jun 13, 2023
Clear Aligner
K223517
Wuxi EA Medical Instruments Technologies Limited.
Dental · 202d
Cleared May 22, 2023
3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
K231464
3M Company, Unitek Orthodontic Products
Dental · 3d
Cleared Apr 24, 2023
STR8 Clear Aligner
K223141
Str8 Oral Care
Dental · 202d
Cleared Apr 17, 2023
Custom-made Invisible Aligners
K223454
Zhejiang Yinchili Medical Technology Co., Ltd.
Dental · 152d
Cleared Apr 05, 2023
Nightwear Aligners
K221537
Smylio, Inc.
Dental · 313d
Cleared Mar 16, 2023
Ensmile
K222619
Ensmile Pvt, Ltd.
Dental · 198d
Cleared Feb 24, 2023
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
K221845
Blue Sky Bio, LLC
Dental · 245d
Cleared Feb 09, 2023
Toothsi, Smilealigners
K223338
Makeo Healthcare Technologies Private Limited
Dental · 100d
Cleared Dec 22, 2022
Invisalign System, Pre-Formed Attachment System
K222894
Align Technology, Inc.
Dental · 90d
Cleared Dec 20, 2022
Al Smile Aligner
K222308
Nanjing Jiahe Dental Technology Co., Ltd.
Dental · 141d
Cleared Nov 25, 2022
DentCare Aligners
K222918
Dentcare Dental Lab Pvt , Ltd.
Dental · 60d
Cleared Nov 03, 2022
Tera Harz Clear
K223355
Graphy, Inc.
Dental · 1d
Cleared Oct 13, 2022
CREOKORREKT Aligners
K211427
Creodent Prosthetics, Ltd.
Dental · 524d
Cleared Oct 07, 2022
Nuvola
K222418
Gruppo Europeo Ortodonzia Srl
Dental · 58d