Arcad Aligners
Top and Bottom Aligners
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1), Sichuan (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Envista (Suzhou) Medical Device Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Envista (Sichuan) Medical Device Co., Ltd. | Ziyang | Sichuan | Contract manufacturer | 4 |
| Hangzhou Chohotech Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 4 |
| Shanghai EA Medical Instruments Co., Ltd. | Yangpu District | Shanghai | Manufacturer | 1 |
Record
| Listed by | Arcadlab, United States |
|---|---|
| FDA product code | PNN |
| Device type | Orthodontic Software |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| 510(k) | K192244 |
| Record published | 2023-11-17 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Clear Orthodontic Aligners | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cerec Ortho Software | Sirona Dental Systems Gmbh | 4 |
| Inbrace Teeth Straightening System | Swift Health Systems, Inc. | 4 |
| InBrace Teeth Straightening System (Gen 2.0) | Swift Health Systems, Inc. | 3 |
| Ortho System | 3Shape A/S | 3 |
| Splint Design | 3Shape A/S | 2 |
| Progressive Orthodontics App | Progressive America, Inc. | 2 |
| CS Model+ | Carestream Dental LLC | 2 |
| Dibs AI | Orthoselect | 1 |
| Automate | 3SHAPE Trios A/S | 1 |
| Automate | 3Shape A/S | 1 |
| Orchestrate 3D | Orchestrate 3D | 1 |
| Medit Orthodontic Suite | Medit Corp. | 1 |
Showing 12 of 20. All products under Orthodontic Software
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.