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Orthodontic plastic bracket. The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion. The device moves the teeth by continuous gentle force for…
Orthodontic plastic bracket. The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion. The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion. A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.
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 | John’s Dental Laboratory Inc |
|---|---|
| FDA product code | NXC |
| Device type | Aligner, Sequential |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| 510(k) | K213297 |
| Record published | 2022-09-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3014680794 | In distribution |
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 |
| Clear Image Aligner | Specialty Appliances, LLC | 35 |
| Spark | Ormco Corporation | 16 |
| Clarity™ Aligners | 3M Unitek | 14 |
| Clarity™ | Solventum Orthodontics Corporation | 13 |
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.