Manufacturer registered with FDA
Zien Medical Technologies LLC
Salt Lake City, UT, 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
- 937 registrations outside the US
- Establishments
- 1United States
Registered in 9 markets
Where regulators' registries name Zien Medical Technologies 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 | Zien Medical Technologies LLC | 2 device types | — | Below |
| Brazil | ANVISA | Manufacturer | ZIEN MEDICAL TECHNOLOGIES INCZIEN MEDICAL TECHNOLOGIES, INC. · ZIEN Medical Technologies, Inc. | 7 | 2021–2022 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | ZIEN Medical Technologies, LLC | 7 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | ZIEN Medical Technologies, LLC | 7 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | ZIEN MEDICAL TECHNOLOGIES, LLCZIEN MEDICAL TECHNOLOGIES, INC. | 5 | 2015–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Zien Medical Technologies | 3 | 2025–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ZIEN MEDICAL TECHNOLOGIESZIEN MEDICAL TECHNOLOGIES, LLC | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | ZIEN Medical TechnologiesZIEN Medical Technologies, Inc. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ZIEN Medical Technologies, Inc. | 2 | 2017–2022 | 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 Zien Medical Technologies 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 |
|---|---|---|---|---|
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | Forceps, Rongeur, Surgical | 2021 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | File, Bone, Surgical | 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 |
|---|---|---|
| ZIEN MEDICAL TECHNOLOGIES LLCFDA reg. 3009756153 | Salt Lake City, UT, United States | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047676). 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.