Splint Design
3Shape Splint Design is CAD software for designing customized splints and mouthguards or nightguards from three-dimensional orthodontic scans. A virtual articulator simulates jaw movement…
3Shape Splint Design is CAD software for designing customized splints and mouthguards or nightguards from three-dimensional orthodontic scans. A virtual articulator simulates jaw movement as part of appliance planning.
The software supports intraoral surface scans and STL surface-model files. Its functions include two-dimensional measurement tools, an occlusion map, appliance design and appliance export. These tools operate on digital models; the software has no patient contact.
Listed Item
Dental treatment application software
From Design to Production
The splint workflow supports production with a 3D printer or milling machine using materials included in the compatible workflow. The user controls fabrication of the finished appliance. The digital design and export functions provide the model for that separate production step.
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 | 3Shape A/S, Denmark |
|---|---|
| FDA product code | PNN |
| Device type | Orthodontic Software |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K191911 |
| Record published | 2021-05-27 |
| Record revised | 2023-02-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2023-02-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R1.0 | In distribution | |
| 1.1.x | Withdrawn |
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 |
| 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 |
|---|---|
| K191911 | 2019-11-27 |
| K180941 | 2018-10-17 |
| K171634 | 2018-01-17 |
| K163677 | 2017-04-20 |
| K152086 | 2016-04-28 |
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.