Inbrace Teeth Straightening System
InBrace is an orthodontic system combining treatment-planning software with patient-specific appliances designed to move teeth. Its lingual appliance is positioned behind the teeth, while…
InBrace is an orthodontic system combining treatment-planning software with patient-specific appliances designed to move teeth. Its lingual appliance is positioned behind the teeth, while digital planning supports the design of an individualized treatment setup.
The listed family includes upper and lower patient kits, a standard kit and a digital enhancement item. These are components or planning assets within the system, not interchangeable descriptions of one patient’s complete setup.
Planning and Appliance
The treatment workflow uses digital planning to design an appliance configuration for an individual case. The behind-the-teeth placement is a defining feature of the InBrace appliance system.
The family covers both physical patient kits and a digital planning enhancement. The particular contents and configuration depend on the selected item.
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 | Swift Health Systems, Inc., United States |
|---|---|
| FDA product code | PNN |
| Device type | Orthodontic Software |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Record published | 2022-10-03 |
| Record revised | 2022-10-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Digital Engancement | In distribution | |
| Lower Patient Kit | In distribution | |
| Upper Patient Kit | In distribution | |
| Standard Patient Kit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cerec Ortho Software | Sirona Dental Systems Gmbh | 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 |
| Medit Orthodontic Suite | Medit Corp. | 1 |
Showing 12 of 20. All products under Orthodontic Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203442 | 2021-02-19 |
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.