Risas Reveal® Aligners

Risas Reveal® Aligners Retainer Single Arch

Registry build 21.09.26
14manufacturers in China registered for this device type
140catalogue 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 Risas Reveal® 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 2021-07-14
Record revised 2025-12-30 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Distribution end date 2023-07-18
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Risas Reveal® Aligners
Catalogue number Size Status
133-AL19 In distribution
133-AL36 In distribution
133-AL15 In distribution
133-AL38 In distribution
133-AL55 In distribution
133-AL4 In distribution
133-AL5 In distribution
133-AL46 In distribution
133-AL2 In distribution
133-AL78 In distribution
133-AL37 In distribution
133-AL74 In distribution
133-AL35 In distribution
133-AL9 In distribution
133-AL1 In distribution
133-AL34 In distribution
133-AL22 In distribution
133-AL72 In distribution
133-AL18 In distribution
133-AL76 In distribution
133-AL25 In distribution
133-AL53 In distribution
133-FLEX In distribution
133-AL13 In distribution
133-AL7 In distribution
133-AL49 In distribution
133-AL10 In distribution
133-AL24 In distribution
133-AL29 In distribution
133-AL32 In distribution
133-AL40 In distribution
133-AL11 In distribution
133-AL8 In distribution
133-AL62 In distribution
133-AL3 In distribution
133-ALUS In distribution
133-AL48 In distribution
133-AL59 In distribution
133-STAND In distribution
133-AL12 In distribution
133-RMA In distribution
133-AL42 In distribution
133-AL30 In distribution
133-AL51 In distribution
133-AL54 In distribution
133-AL58 In distribution
133-AL26 In distribution
133-RTS In distribution
133-RT In distribution
133-AL39 In distribution
133-AL66 In distribution
133-AL64 In distribution
133-AL52 In distribution
133-AL47 In distribution
133-AL43 In distribution
133-AL16 In distribution
133-AL50 In distribution
133-AL28 In distribution
133-AL56 In distribution
133-AL80 In distribution
133-AL70 In distribution
133-AL6 In distribution
133-AL57 In distribution
133-AL27 In distribution
133-AL20 In distribution
133-AL41 In distribution
133-AL21 In distribution
133-AL17 In distribution
133-AL31 In distribution
133-AL68 In distribution
133-AL23 In distribution
133-AL33 In distribution
133-AL14 In distribution
133-AL45 In distribution
133-ALS In distribution
133-AL44 In distribution
133-AL60 In distribution
133-AL32 Withdrawn
133-AL31 Withdrawn
133-AL11 Withdrawn
133-AL8 Withdrawn
133-AL44 Withdrawn
133-AL43 Withdrawn
133-AL30 Withdrawn
133-FLEX Withdrawn
133-AL19 Withdrawn
133-AL23 Withdrawn
133-AL45 Withdrawn
133-AL46 Withdrawn
133-AL59 Withdrawn
133-AL48 Withdrawn
133-AL25 Withdrawn
133-AL18 Withdrawn
133-AL6 Withdrawn
133-AL7 Withdrawn
133-AL3 Withdrawn
133-AL54 Withdrawn
133-AL2 Withdrawn
133-AL39 Withdrawn
133-AL9 Withdrawn
133-RMA Withdrawn
133-AL20 Withdrawn
133-AL60 Withdrawn
133-AL56 Withdrawn
133-AL50 Withdrawn
133-AL58 Withdrawn
133-AL41 Withdrawn
133-AL52 Withdrawn
133-RT Withdrawn
133-AL42 Withdrawn
133-AL5 Withdrawn
133-AL38 Withdrawn
133-AL34 Withdrawn
133-AL55 Withdrawn
133-AL35 Withdrawn
133-AL29 Withdrawn
133-AL28 Withdrawn
133-AL49 Withdrawn
133-AL47 Withdrawn
133-AL57 Withdrawn
133-AL40 Withdrawn
133-RTS Withdrawn
133-AL51 Withdrawn
133-AL36 Withdrawn
133-AL21 Withdrawn
133-CASE Withdrawn
133-AL53 Withdrawn
133-AL37 Withdrawn
133-AL10 Withdrawn
133-AL33 Withdrawn
133-AL13 Withdrawn
133-AL14 Withdrawn
133-AL26 Withdrawn
133-AL27 Withdrawn
133-AL24 Withdrawn
133-AL22 Withdrawn
133-FULL Withdrawn
133-AL1 Withdrawn
133-AL12 Withdrawn
133-AL4 Withdrawn

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
Absolute® Clear Aligners Ortho Organizers, Inc. 65
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