Data / Medical devices / United States / Oral Biotech LLC
Oral Biotech LLC: FDA-registered device maker in Albany, OR, United States, 1 510(k) clearance
Oral Biotech LLC is registered with the FDA (registration 3005686375) in Albany, OR, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 20, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005686375
- FEI number
- 3003422682
- Address
- 812 Water Ave Ne, Albany, OR, United States, 97321
- Owner or operator
- Oral Biotech (9085004)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- March 13, 2007
- Registered through
- 2026
- Brand names listed
- CARISCREEN ATP BACTERIAL TEST, CariFree Fluoride Varnish, CariFree Mineral Enhanced Floss, Carifree Toothbrush
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Culture Media, Non-Selective And Differential | JSH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| May 20, 2016 | K153334 | Oral-B 5% Sodium Fluoride Varnish | LBH | Substantially Equivalent | Young Dental Manufacturing Co. 1, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Floss, Dental
- All makers of Varnish, Cavity
- All makers of Culture Media, Non-Selective And Differential
- All makers of Toothbrush, Manual
Updated May 20, 2016. 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.