Absolute® Clear Aligners

Absolute® Clear Aligners Standard

Registry build 21.09.26
14manufacturers in China registered for this device type
65catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (4), Zhejiang (2), Jiangsu (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NXC
Manufacturer City Province Registered as Device types
Ningbo Sezen Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 7
Envista (Suzhou) Medical Device Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Envista (Sichuan) Medical Device Co., Ltd. Ziyang Sichuan Contract manufacturer 4
Sichuan Yinli Medical Equipment Co., Ltd. Ziyang Sichuan Contract manufacturer 1
Xi’an Henghui Technology, Ltd Xi’An Shaanxi Contract manufacturer 1
Aidite (Qinhuangdao) Technology Co., Ltd. Qinhuangdao Hebei Repacker / relabeller 17
Shandong Huge Dental Material Corporation Rizhao Shandong Manufacturer 17
Shenzhen Sunmc Dental Technology Co., Ltd. Shenzhen Guangdong Manufacturer 17
Modern Dental Laboratory (DG) Co., Ltd. Dongguan Guangdong Contract manufacturer 15
Royal Dental Lab Shenzhen Guangdong Manufacturer 12
Wuxi EA Medical Instruments Technologies Limited Wuxi Jiangsu Repacker / relabeller 6
Shanghai Smartee Denti-Technology Co., Ltd. Shanghai Shanghai Exporter 5

Showing 12 of 14. All 14 manufacturers in China registered for Aligner, Sequential

Record

Regulatory record for Absolute® Clear Aligners
Listed by Ortho Organizers, Inc., United States
FDA product code NXC
Device type Aligner, Sequential
Device class Class 2
Regulation 21 CFR 872.5470
Establishment Specification developer, Repacker / relabeller, Manufacturer
Record published 2022-06-23
Record revised 2025-12-30 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Absolute® Clear Aligners
Catalogue number Size Status
140-AL54 In distribution
140-AL29 In distribution
140-AL49 In distribution
140-AL55 In distribution
140-AL21 In distribution
140-AL53 In distribution
140-AL47 In distribution
140-RMA In distribution
140-AL9 In distribution
140-AL44 In distribution
140-AL22 In distribution
140-AL6 In distribution
140-AL57 In distribution
140-AL27 In distribution
140-AL43 In distribution
140-AL14 In distribution
140-AL24 In distribution
140-AL2 In distribution
140-AL19 In distribution
140-AL56 In distribution
140-AL8 In distribution
140-AL58 In distribution
140-FLEX In distribution
140-AL52 In distribution
140-AL31 In distribution
140-AL26 In distribution
140-AL45 In distribution
140-AL12 In distribution
140-AL7 In distribution
140-AL17 In distribution
140-AL60 In distribution
140-AL32 In distribution
140-AL15 In distribution
140-AL25 In distribution
140-AL59 In distribution
140-AL13 In distribution
140-AL35 In distribution
140-AL50 In distribution
140-AL34 In distribution
140-AL5 In distribution
140-AL20 In distribution
140-STAND In distribution
140-AL39 In distribution
140-AL33 In distribution
140-RT In distribution
140-AL11 In distribution
140-AL1 In distribution
140-AL3 In distribution
140-AL37 In distribution
140-AL46 In distribution
140-RTS In distribution
140-AL41 In distribution
140-AL10 In distribution
140-AL16 In distribution
140-AL23 In distribution
140-AL40 In distribution
140-AL30 In distribution
140-AL48 In distribution
140-AL36 In distribution
140-AL18 In distribution
140-AL28 In distribution
140-AL42 In distribution
140-AL38 In distribution
140-AL4 In distribution
140-AL51 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
SLX® Clear Aligners Ortho Organizers, Inc. 176
Reveal® Aligners Ortho Organizers, Inc. 149
Reveal® Clear Aligners Ortho Organizers, Inc. 148
ClearArc Aligners Ortho Organizers, Inc. 148
Risas Reveal® Aligners Ortho Organizers, Inc. 140
3M™ Clarity™ 3M Unitek 56
Reveal™ Aligners Henry Schein, Inc. 52
Clear Image Aligner Specialty Appliances, LLC 35
Spark Ormco Corporation 16
Clarity™ Aligners 3M Unitek 14
Clarity™ Solventum Orthodontics Corporation 13
Thermoplier® Dentsply Sirona Orthodontics Inc. 12

Showing 12 of 232. All products under Aligner, Sequential

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer