Medit Orthodontic Suite
Catalogue number 2.0, listed by Medit Corp., South Korea, under Orthodontic Software. 4 manufacturers in China are registered for this product code.
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 | Medit Corp., South Korea |
|---|---|
| FDA product code | PNN |
| Device type | Orthodontic Software |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2025-05-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.0 | 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 |
| Arcad Aligners | Arcadlab | 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.