Manufacturer registered with FDA
Viant Medical, LLC
Foxborough, MA, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 13411 registrations outside the US
- Establishments
- 1Mexico
Registered in 13 markets
Where regulators' registries name Viant Medical, LLC 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 | Viant Medical, LLC | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Viant Medical, LLC | 285 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | VIANT MEDICAL LLCVIANT MEDICAL, INC. · VIANT MEDICAL, LLC · +1 | 27 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | VIANT MEDICAL, LLCViant Medical Inc. · Viant Medical LLC · +2 | 27 | 2000–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Viant Medical LLC | 17 | 2019–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | VIANT MEDICAL, LLC | 14 | 2004–2017 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Viant Medical, LLC | 13 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | VIANT MEDICAL, LLCViant Medical, Inc. | 8 | 2016–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Viant Medical, LLCVIANT MEDICAL, LLC · Viant Medical, Inc. | 6 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | VIANT MEDICAL, LLC | 5 | 2024–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Viant Medical, LLCViant Medical LLC | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | VIANT MEDICAL, LLCVIANT MEDICAL INC. | 3 | 2019–2021 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | VIANT MEDICAL, LLC. | 2 | 2019–2025 | 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 Viant Medical, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Align Technology | 2011 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Invisalign Cheek Retractor | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Viant Mexicana de Servicios, S. de R.L. de C.V.FDA reg. 3006535925 | TIJUANA Baja California, Mexico | Contract manufacturer |
Other names on FDA records
Viant Mexicana de Servicios, S. de R.L de C.V.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9043339). 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.