Data / Medical devices / United States / Orabio, Inc.
Orabio, Inc.: FDA-registered device maker in Pittsburgh, PA, United States, 1 510(k) clearance
Orabio, Inc. is registered with the FDA (registration 3030444281) in Pittsburgh, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 15, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030444281
- Address
- 285 Kappa Dr Ste 100, Pittsburgh, PA, United States, 15238
- Owner or operator
- OraBio, Inc. (10089851)
- Roles
- Repackager or relabeler
- First device listed
- February 4, 2026
- Registered through
- 2026
- Brand names listed
- BIOXTRA, PERIOVANCE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Saliva, Artificial | LFD | U | Repackager or relabeler | 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 15, 2007 | K072306 | BIOXTRA MOISTURIZING GEL | LFD | Substantially Equivalent | Bio-X Healthcare S.A. | accessdata.fda.gov |
Compare with other makers
Updated November 15, 2007. 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.