Manufacturer registered with FDA
2z Medical
Bala Cynwyd, PA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 12010–2010
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name 2z Medical 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 | 2z Medical | 1 clearances | 2010–2010 | Below |
| Taiwan | TFDA | Manufacturer | 2Z MEDICAL | 1 | 2011–2011 | 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 2z Medical currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Cervical (for Mild Sleep Apnea) PillowMYB · Class 2 | — | Maker | ZzomaZzoma Positional DeviceZzoma Positional Sleeper | 2010 |
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 |
|---|---|---|
| Sleep Specialists, LLCFDA reg. 3008812550 | Bala Cynwyd, PA, United States | Specification developer |
Other names on FDA records
Sleep Specialists, LLC
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034700). 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.