3m™ Clarity™
3M™ Clarity™ Aligners AttachTemp Single Arch Replacement, 359-486
14manufacturers in China registered for this device type
56catalogue numbers in this listing
1510(k) clearance
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 | 3M Unitek, United States |
|---|---|
| FDA product code | NXC |
| Device type | Aligner, Sequential |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Record published | 2020-06-29 |
| Record revised | 2021-02-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 359-471 | 2 | In distribution | |
| 359-490 | 2 | In distribution | |
| 359-486 | In distribution | ||
| 359-508 | In distribution | ||
| 358-503 | 2 | In distribution | |
| 358-506 | In distribution | ||
| 359-488 | In distribution | ||
| 359-504 | In distribution | ||
| 359-503 | 2 | In distribution | |
| 359-452 | In distribution | ||
| 359-822 | In distribution | ||
| 359-485 | 2 | In distribution | |
| 359-458 | In distribution | ||
| 359-998 | In distribution | ||
| 358-510 | In distribution | ||
| 358-505 | 2 | In distribution | |
| 359-837 | In distribution | ||
| 359-472 | In distribution | ||
| 359-835 | In distribution | ||
| 359-831 | In distribution | ||
| 359-830 | In distribution | ||
| 358-501 | 2 | In distribution | |
| 358-504 | In distribution | ||
| 358-484 | In distribution | ||
| 359-502 | In distribution | ||
| 359-501 | 2 | In distribution | |
| 359-507 | 2 | In distribution | |
| 359-824 | In distribution | ||
| 359-836 | In distribution | ||
| 358-512 | 2 | In distribution | |
| 359-510 | In distribution | ||
| 359-820 | In distribution | ||
| 359-827 | In distribution | ||
| 359-450 | 2 | In distribution | |
| 359-443 | In distribution | ||
| 359-484 | 2 | In distribution | |
| 358-507 | 2 | In distribution | |
| 359-823 | In distribution | ||
| 359-483 | 2 | In distribution | |
| 359-509 | 2 | In distribution | |
| 358-483 | In distribution | ||
| 359-455 | 2 | In distribution | |
| 359-487 | 2 | In distribution | |
| 358-508 | In distribution | ||
| 359-821 | In distribution | ||
| 358-511 | In distribution | ||
| 359-506 | In distribution | ||
| 359-826 | In distribution | ||
| 359-825 | In distribution | ||
| 359-832 | In distribution | ||
| 359-505 | 2 | In distribution | |
| 359-834 | In distribution | ||
| 359-833 | In distribution | ||
| 359-491 | In distribution | ||
| 358-509 | 2 | In distribution | |
| 358-502 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163689 | 2017-01-27 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 3M Company | UDI-DI | 2024-11-22 | Class II | Software design (manufacturing process) | Attachments may not mate with the tooth as intended in the digital treatment design. | 171 orders |
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.