Manufacturer registered with FDA
Versah LLC
Jackson, MI, United States. Lists 2 dental device types with FDA across 2 registered establishments.
- Device types listed
- 2
- Brands and models
- 23
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1489 registrations outside the US
- Establishments
- 2United States
Registered in 14 markets
Where regulators' registries name Versah 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 | Versah LLC | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | VERSAH, LLC | 21 | 2016–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Versah LLC | 15 | 2021–2025 | Pure Global AI |
| Colombia | INVIMA | Registration holder | VERSAH LLC | 12 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Versah, LLC | 8 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Versah LLC | 7 | 2017–2020 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | VERSAH LLCVERSAH LLC. | 7 | 2018–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Versah, LLC | 6 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Versah LLCVersah, LLC | 4 | 2019–2021 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | VERSAH, LLC | 2 | 2018–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | VERSAH LLC | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | VERSAH LLC | 2 | 2023–2023 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Versah, LLC | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | VERSAH LLC | 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 Versah 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 |
|---|---|---|---|---|
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | C-Guides SleevesDensah BursG-Stop KeysG-Stop Vertical GaugesShort Densah BursShort Tapered Pilot DrillTapered Pilot DrillZygoma C-Guide SleeveZygoma Densah BursZygoma Guided Keys 1 moreZygoma Tapered Drill | 2017 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | C-Guides SleevesDensah BursG-Stop KeysG-Stop Vertical GaugesParallel Pin and Parallel Pin XLShort Densah BursShort Tapered Pilot DrillTapered Pilot DrillZygoma C-Guide SleevesZygoma Densah Burs 2 moreZygoma Guided KeysZygoma Tapered Drill | 2014 |
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 |
|---|---|---|
| VERSAH LLCFDA reg. 3011117802 | Jackson, MI, United States | Manufacturer |
| VERSAH, LLCFDA reg. 3017835246 | Jackson, MI, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046965). 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.