Manufacturer registered with FDA
BiometerPlus USA, Inc.
Fremont, CA, 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 BiometerPlus USA, Inc. 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 | Maker | BIO Toothbrush | 2026 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | BIO Dental Radiographic Film | 2026 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | BIO Dental Floss | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BiometerPlus USA, Inc.FDA reg. 3010830834 | Fremont, CA, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046647). 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.