ClearArc Aligners
ClearArc™ Retainer Single Arch
14manufacturers in China registered for this device type
148catalogue 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.
| 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
| 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 | 2020-07-13 |
| Record revised | 2025-12-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2023-01-23 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 130-FLEX9 | In distribution | |
| 130-AL59 | In distribution | |
| 130-AL22 | In distribution | |
| 130-AL56 | In distribution | |
| 130-AL4 | In distribution | |
| 130-AL21 | In distribution | |
| 130-AL8 | In distribution | |
| 130-AL45 | In distribution | |
| 130-FLEX3 | In distribution | |
| 130-AL18 | In distribution | |
| 130-AL27 | In distribution | |
| 130-AL13 | In distribution | |
| 130-AL44 | In distribution | |
| 130-FLEX8 | In distribution | |
| 130-AL43 | In distribution | |
| 130-AL30 | In distribution | |
| 130-AL32 | In distribution | |
| 130-AL17 | In distribution | |
| 130-AL26 | In distribution | |
| 130-AL9 | In distribution | |
| 130-AL7 | In distribution | |
| 130-AL11 | In distribution | |
| 130-AL55 | In distribution | |
| 130-AL49 | In distribution | |
| 130-AL53 | In distribution | |
| 130-AL34 | In distribution | |
| 130-AL42 | In distribution | |
| 130-FLEX6 | In distribution | |
| 130-AL35 | In distribution | |
| 130-AL36 | In distribution | |
| 130-FLEX5 | In distribution | |
| 130-AL41 | In distribution | |
| 130-AL28 | In distribution | |
| 130-FLEX1 | In distribution | |
| 130-FULL | In distribution | |
| 130-AL1 | In distribution | |
| 130-RMA | In distribution | |
| 130-FLEX4 | In distribution | |
| 130-AL51 | In distribution | |
| 130-AL16 | In distribution | |
| 130-AL24 | In distribution | |
| 130-AL40 | In distribution | |
| 130-AL10 | In distribution | |
| 130-AL5 | In distribution | |
| 130-AL60 | In distribution | |
| 130-FLEX7 | In distribution | |
| 130-AL15 | In distribution | |
| 130-AL52 | In distribution | |
| 130-AL46 | In distribution | |
| 130-AL29 | In distribution | |
| 130-AL50 | In distribution | |
| 130-RT | In distribution | |
| 130-AL33 | In distribution | |
| 130-AL2 | In distribution | |
| 130-AL47 | In distribution | |
| 130-AL3 | In distribution | |
| 130-AL23 | In distribution | |
| 130-FLEX | In distribution | |
| 130-AL12 | In distribution | |
| 130-RTS | In distribution | |
| 130-AL14 | In distribution | |
| 130-AL25 | In distribution | |
| 130-AL20 | In distribution | |
| 130-AL48 | In distribution | |
| 130-AL37 | In distribution | |
| 130-AL57 | In distribution | |
| 130-AL58 | In distribution | |
| 130-AL31 | In distribution | |
| 130-FLEX2 | In distribution | |
| 130-AL39 | In distribution | |
| 130-AL6 | In distribution | |
| 130-AL54 | In distribution | |
| 130-AL19 | In distribution | |
| 130-AL38 | In distribution | |
| 130-AL21 | Withdrawn | |
| 130-AL6 | Withdrawn | |
| 130-AL31 | Withdrawn | |
| 130-AL39 | Withdrawn | |
| 130-AL37 | Withdrawn | |
| 130-AL26 | Withdrawn | |
| 130-FLEX6 | Withdrawn | |
| 130-AL56 | Withdrawn | |
| 130-AL49 | Withdrawn | |
| 130-AL25 | Withdrawn | |
| 130-AL24 | Withdrawn | |
| 130-AL4 | Withdrawn | |
| 130-FLEX2 | Withdrawn | |
| 130-AL30 | Withdrawn | |
| 130-AL44 | Withdrawn | |
| 130-AL48 | Withdrawn | |
| 130-AL35 | Withdrawn | |
| 130-AL46 | Withdrawn | |
| 130-FLEX1 | Withdrawn | |
| 130-AL23 | Withdrawn | |
| 130-FULL | Withdrawn | |
| 130-AL58 | Withdrawn | |
| 130-AL40 | Withdrawn | |
| 130-RT | Withdrawn | |
| 130-AL11 | Withdrawn | |
| 130-AL34 | Withdrawn | |
| 130-AL1 | Withdrawn | |
| 130-AL2 | Withdrawn | |
| 130-AL3 | Withdrawn | |
| 130-AL20 | Withdrawn | |
| 130-AL10 | Withdrawn | |
| 130-AL45 | Withdrawn | |
| 130-FLEX9 | Withdrawn | |
| 130-AL13 | Withdrawn | |
| 130-AL52 | Withdrawn | |
| 130-AL54 | Withdrawn | |
| 130-AL19 | Withdrawn | |
| 130-AL50 | Withdrawn | |
| 130-AL27 | Withdrawn | |
| 130-AL8 | Withdrawn | |
| 130-AL60 | Withdrawn | |
| 130-AL43 | Withdrawn | |
| 130-AL42 | Withdrawn | |
| 130-RTS | Withdrawn | |
| 130-AL53 | Withdrawn | |
| 130-AL16 | Withdrawn | |
| 130-AL41 | Withdrawn | |
| 130-AL57 | Withdrawn | |
| 130-AL32 | Withdrawn | |
| 130-AL33 | Withdrawn | |
| 130-AL7 | Withdrawn | |
| 130-RMA | Withdrawn | |
| 130-FLEX8 | Withdrawn | |
| 130-AL59 | Withdrawn | |
| 130-AL36 | Withdrawn | |
| 130-AL18 | Withdrawn | |
| 130-AL15 | Withdrawn | |
| 130-AL14 | Withdrawn | |
| 130-AL9 | Withdrawn | |
| 130-AL5 | Withdrawn | |
| 130-FLEX4 | Withdrawn | |
| 130-FLEX5 | Withdrawn | |
| 130-FLEX7 | Withdrawn | |
| 130-FLEX3 | Withdrawn | |
| 130-AL47 | Withdrawn | |
| 130-AL38 | Withdrawn | |
| 130-AL12 | Withdrawn | |
| 130-AL22 | Withdrawn | |
| 130-AL55 | Withdrawn | |
| 130-AL28 | Withdrawn | |
| 130-AL29 | Withdrawn | |
| 130-AL51 | Withdrawn | |
| 130-AL17 | Withdrawn | |
| 130-FLEX | Withdrawn |
Same 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 |
| Risas Reveal® Aligners | Ortho Organizers, Inc. | 140 |
| 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.