Manufacturer registered with FDA
Somnics, Inc.
Zhubei City, Taiwan. Lists 1 dental device type with FDA across 2 registered establishments, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 22016–2023
- Markets registered in
- 611 registrations outside the US
- Establishments
- 2Taiwan, United States
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Somnics, 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 | Somnics, Inc. | 2 clearances | 2016–2023 | Below |
| European Union | EUDAMED | Manufacturer | Somnics, Inc. | 5 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Somnics Inc | 3 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Somnics, Inc. | 1 | 2024–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Somnics, Inc. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Somnics Inc. | 1 | 2022–2022 | 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 Somnics, 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 |
|---|---|---|---|---|
| Intraoral Pressure Gradient DeviceOZR · Class 2 | — | Maker | iNAP One Sleep Therapy SystemThe iNAP One Sleep Therapy System | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Somnics, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Somnice, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 May 2020 | K193460 | The iNAP One Sleep Therapy System | Somnice, Inc. | OZR Intraoral Pressure Gradient Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Somnics HealthFDA reg. 3017791238 | Redwood City, CA, United States | Complaint file establishment |
| SOMNICS, INC.FDA reg. 3014674517 | Zhubei City Hsinchu(County), Taiwan | Manufacturer |
Other names on FDA records
Somnics Health
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058120). 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.