Manufacturer registered with FDA
3DISC Americas
Herndon, VA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 4
- 510(k) clearances
- 12013–2013
- Markets registered in
- 613 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name 3DISC Americas as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | 3DISC Americas | 1 clearances | 2013–2013 | Below |
| Taiwan | TFDA | Manufacturer | 3D IMAGING& SIMULATION CORP. AMERICAS | 6 | 2020–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | 3D IMAGING AND SIMULATION CORP. AMERICAS | 2 | 2020–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | 3DISC Americas | 2 | 2022–2023 | Pure Global AI |
| South Korea | MFDS | Manufacturer | 3D Imaging and Simulation Corp. Americas | 2 | 2019–2020 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | 3D Imaging & Simulation Corp Americas | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What 3DISC Americas currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | AVAHeron IOSOVO 3OVO IOS | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names 3DISC Americas as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 Sep 2013 | K131442 | FIRECR DENTALIMAGING SYSTEM | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: DIGIRAY Corp. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| 3D Imaging And Simulation Corp. AmericasFDA reg. 3008321355 | Herndon, VA, United States | Manufacturer |
Other names on FDA records
3D Imaging& Simulation Corp. Americas
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033930). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.