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., Ormco Corporation and Blue Sky Bio, LLC.

143
Total
143
Cleared
170d
Avg days
1998
Since
143 devices
25–48 of 143
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 26, 2023
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
K232233
Align Technology, Inc.
Dental · 61d
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