Data / Medical devices / United States / Zyris, Inc.
Zyris, Inc.: FDA-registered device maker in Santa Barbara, CA, United States, 1 510(k) clearance
Zyris, Inc. is registered with the FDA (registration 2032574) in Santa Barbara, CA, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 18, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2032574
- FEI number
- 3003706371
- Address
- 6868A Cortona Dr, Santa Barbara, CA, United States, 93117
- Owner or operator
- Zyris, Inc. (9050190)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 25, 2013
- Registered through
- 2027
- Brand names listed
- Barrier Sleeves, ISODRY, ISOLITE, Isolite, Isolite 3, Isolite Anterior Isolation System, Isolite Core, Isolite Core+ and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | 1 | Manufacturer | accessdata.fda.gov |
| Dental Barriers And Sleeves | PEM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 18, 2024 | K242435 | Dental Barrier and Sleeves | PEM | Substantially Equivalent | Wellmed Dental Medical Supply Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Retractor, Dental
- All makers of Mouthpiece, Saliva Ejector
- All makers of Evacuator, Oral Cavity
- All makers of Drape, Surgical, Exempt
- All makers of Dental Barriers And Sleeves
Updated October 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.