Manufacturer registered with FDA
Akervall Technologies Inc.
Saline, MI, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 58 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name Akervall Technologies Inc. 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 | Akervall Technologies Inc. | 2 device types | — | Below |
| Australia | TGA | Manufacturer | Akervall Technologies Inc | 3 | 2017–2017 | Pure Global AI |
| South Korea | MFDS | Manufacturer | AKERVALL TECHNOLOGIESAKERVALL TECHNOLOGIES, Inc. · Akervall Technologies | 3 | 2016–2019 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | AKERVALL TECHNOLOGIES | 1 | 2019–2019 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Akervall Technologies, Inc. | 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 Akervall Technologies Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | — | 2024 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | 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 |
|---|---|---|
| AKERVALL TECHNOLOGIESFDA reg. 3011547262 | Saline, MI, United States | Complaint file establishment, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048970). 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.