Registered with FDA
Prime Distributors LLC
Brooklyn, NY, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Prime Distributors LLC 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 | — | 2004 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | — | 2017 |
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 |
|---|---|---|
| PRIME DISTRIBUTORS LLCFDA reg. 3004585750 | BROOKLYN, NY, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9063520). 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.