Manufacturer registered with FDA
Zyris, Inc.
Santa Barbara, CA, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 565 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name Zyris, 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 | Zyris, Inc. | 3 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Zyris, Inc. | 58 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Zyris, Inc. | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Zyris Inc | 2 | 2019–2019 | Pure Global AI |
| Israel | AMAR | Manufacturer | Zyris, 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 Zyris, 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Isolite Mouthpiece | 2015 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | IsoliteIsolite 3Isolite CoreIsolite Core+Isolite ProIsovacIsovac 2 | 2026 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | ISODRYISOLITEIsolite Anterior Isolation SystemIsovacOperating Room Adapter (ORA)Zyris Lip Retractor | 2013 |
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 |
|---|---|---|
| ZYRIS, INC.FDA reg. 2032574 | Santa Barbara, CA, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9050190). 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.