510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NXCClass II

Aligner, Sequential

21 CFR 872.5470 / Dental
FDA source (opens on fda.gov)

NXC is the FDA product code for Aligner, Sequential, a class II device type, regulated under 21 CFR 872.5470. FDA's definition for this code reads: "The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion". As of , FDA records hold 145 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NXC
Device name
Aligner, Sequential
FDA definition
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
145
Ingested recalls
2

Clearances, product code NXC

By decision year
145 clearances under product code NXC with a decision year between 1998 and 2026, 2021 the highest year at 20.
Show the numbers
510(k) clearances under FDA product code NXC by decision year
YearClearances
19981
20041
20071
20082
20092
20101
20122
20134
20152
20161
20173
201811
201916
202016
202120
202219
202313
202414
202511
20265

Applicants with the most clearances

Product code NXC
Applicants holding the most 510(k) clearances under product code NXC
ApplicantClearances
Align Technology, Inc.12
ClearCorrect, LLC4
Smylio4
3M Company, Unitek Orthodontic Products3
Blue Sky Bio, LLC3
Dentsply Sirona Inc3
Ormco Corporation3
3D Global Biotech Inc.2
3M Company2
Allesee Orthodontic Appliances, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 99 companies shown, in name order