Orchestrate 3d
Orthodontic Software
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Orchestrate 3D, United States |
|---|---|
| FDA product code | PNN |
| Device type | Orthodontic Software |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| 510(k) | K181112 |
| Record published | 2022-06-21 |
| Record revised | 2023-04-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | 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 |
| Arcad Aligners | Arcadlab | 1 |
| Medit Orthodontic Suite | Medit Corp. | 1 |
Showing 12 of 20. All products under Orthodontic Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181112 | 2018-11-26 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orchestrate Orthodontic Technologies, Inc. | 510(k) number | 2021-11-11 | Class II | Process control | Due to product label/labeling being altered from it’s approved state. | 127 copies | 2024-01-10 |
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.