Registered with FDA
Oral Biotech
Albany, OR, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Oral Biotech currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Carifree Toothbrush | 2019 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | CariFree Mineral Enhanced Floss | 2026 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | CariFree Fluoride Varnish | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Oral Biotech lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Young Innovations Inc (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 May 2016 | K153334 | Oral-B 5% Sodium Fluoride Varnish | Young Innovations Inc | LBH Cavity Varnish |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Oral Biotech LLCFDA reg. 3005686375 | ALBANY, OR, United States | Complaint file establishment, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9085004). 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.