Clear Image Aligner
Clear Image Aligner Select: Upper
14manufacturers in China registered for this device type
35catalogue 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 | Specialty Appliances, LLC, 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 |
| 510(k) | K071970 |
| Record published | 2016-09-09 |
| Record revised | 2021-02-05 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2017-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 700000 | In distribution | |
| 700025 | In distribution | |
| 700068 | In distribution | |
| 700060 | In distribution | |
| 700030 | In distribution | |
| 700067 | In distribution | |
| 700035 | In distribution | |
| 700015 | In distribution | |
| 700045 | In distribution | |
| 700040 | In distribution | |
| 700050 | In distribution | |
| 700065 | In distribution | |
| 700032 | In distribution | |
| 700066 | In distribution | |
| 700031 | In distribution | |
| 700020 | In distribution | |
| 700010 | In distribution | |
| 700005 | In distribution | |
| 700055 | In distribution | |
| 700070 | In distribution | |
| 700069 | In distribution | |
| 70030 | Withdrawn | |
| 70032 | Withdrawn | |
| 70230 | Withdrawn | |
| 70051 | Withdrawn | |
| 70042 | Withdrawn | |
| 70040 | Withdrawn | |
| 70031 | Withdrawn | |
| 70060 | Withdrawn | |
| 70210 | Withdrawn | |
| 70050 | Withdrawn | |
| 70061 | Withdrawn | |
| 70041 | Withdrawn | |
| 70220 | Withdrawn | |
| 70240 | 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 |
| ClearArc 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 |
| 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.