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
Declining activity - 22 submissions in the last 2 years vs 31 in the prior period
Review times improving: avg 130d recently vs 176d historically

FDA 510(k) Cleared Aligner, Sequential Devices (Product Code NXC)

144 devices
1–24 of 144
Cleared May 08, 2026
Smylio Aligners
K260788
Smylio, Inc.
Dental · 59d
Cleared Apr 15, 2026
SureSmile Aligner (ASSY500020)
K260722
Dentsply Sirona, Inc.
Dental · 41d
Cleared Feb 03, 2026
ZSmile System
K253282
Dror Orthodesign , Ltd.
Dental · 127d
Cleared Jan 07, 2026
Clear Aligner (SCF-3348)
K251454
Beame Medical Technology (Shenzhen) Limited
Dental · 240d
Cleared Nov 07, 2025
Primeprint Direct Aligner
K250739
Dreve Dentamid GmbH
Dental · 241d
Cleared Oct 23, 2025
Invisalign® Palatal Expander System
K252931
Align Technology, Inc.
Dental · 38d
Cleared Oct 09, 2025
Invisalign Specifix Attachment System
K252870
Align Technology, Inc.
Dental · 30d
Cleared Sep 11, 2025
Serafin®
K251758
Tns Co., Ltd.
Dental · 94d
Cleared Aug 29, 2025
Invisalign System
K252380
Align Technology, Inc.
Dental · 30d
Cleared Aug 27, 2025
Additively Manufactured Aligner Resin
K251415
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental · 112d
Cleared Jul 22, 2025
Clear Miracle
K251616
Ods Co., Ltd.
Dental · 56d
Cleared May 21, 2025
MEM Clear Aligner System
K242637
Mem Dental Technology Co., Ltd.
Dental · 260d
Cleared Apr 08, 2025
LuxCreo Clear Aligner System
K250343
LuxCreo, Inc.
Dental · 61d
Cleared Feb 20, 2025
SparkTM Clear Aligner System
K250487
Ormco Corporation
Dental · 1d
Cleared Jan 16, 2025
Pearl Clear Aligner
K242715
Pearl Digital, Inc.
Dental · 128d
Cleared Dec 20, 2024
Fas Aligner System
K242929
Xplora 3D Europe S.L
Dental · 87d
Cleared Dec 19, 2024
Cristaline Aligners Z FLX
K242892
Cristaline Aligners GmbH
Dental · 87d
Cleared Dec 12, 2024
GENIOVA aligners
K233152
Geniova Technologies Sociedad Limitada
Dental · 442d
Cleared Oct 11, 2024
Spark™ Clear Aligner System
K240501
Ormco Corporation
Dental · 233d
Cleared Aug 08, 2024
Illusion Aligner Pro: Illusion Aligner FLX
K233356
Laxmi Dental Export Pvt., Ltd.
Dental · 314d
Cleared Aug 01, 2024
Clear Moves Aligner
K241137
Clear Moves Aligners
Dental · 99d
Cleared Jul 26, 2024
Alien Aligners
K241187
Alien Milling Technologies
Dental · 88d
Cleared Jun 18, 2024
Invisalign System
K241412
Align Technology, Inc.
Dental · 32d
Cleared Apr 05, 2024
DigiLine Direct Print Aligner System
K233935
Park Dental Research Corporation
Dental · 113d

About Product Code NXC - Regulatory Context

510(k) Submission Activity

144 total 510(k) submissions under product code NXC since 1998, with 144 receiving FDA clearance (average review time: 169 days).

Submission volume has declined in recent years - 22 submissions in the last 24 months compared to 31 in the prior period.

FDA 510(k) Review Time - NXC Product Code

Recent submissions under NXC have taken an average of 130 days to reach a decision - down from 176 days historically, suggesting improved FDA processing for this classification.

NXC devices are reviewed by the Dental panel. Browse all Dental devices →