Data / Medical devices / United States / Proguard Health Inc.
Proguard Health Inc.: FDA-registered device maker in Los Angeles, CA, United States, 1 510(k) clearance
Proguard Health Inc. is registered with the FDA (registration 3016710511) in Los Angeles, CA, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 4, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016710511
- Address
- 771 E. 9th street, Los Angeles, CA, United States, 90021
- Owner or operator
- Proguard Health Inc. (10066042)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- April 5, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Contract manufacturer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Contract manufacturer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Contract manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 4, 2022 | K222697 | Disposable Medical Face Mask (DF3-001) | FXX | Substantially Equivalent | Wellmed Dental Medical Supply Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Activator, Ultraviolet, For Polymerization
- All makers of Handpiece, Air-Powered, Dental
- All makers of Cup, Prophylaxis
- All makers of Non-Surgical Gown
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
- All makers of Mask, Surgical
Updated November 4, 2022. 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.