Manufacturer registered with FDA
SMD Manufacturing LLC
Salt Lake City, UT, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name SMD Manufacturing 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 | SMD Manufacturing LLC | 3 device types | — | Below |
| Brazil | ANVISA | Manufacturer | SMD MANUFACTURING, LLC | 3 | 2023–2023 | 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 SMD Manufacturing 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | — | 2016 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | — | 2021 |
| Dental Hygiene KitNXZ · Class 1 | — | Maker | — | 2024 |
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 |
|---|---|---|
| SMD MANUFACTURING LLCFDA reg. 3013075752 | Salt Lake City, UT, United States | Complaint file establishment, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052202). 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.