Manufacturer registered with FDA
Oralkleen Inc.
Phoenix, AZ, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Oralkleen 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 |
|---|---|---|---|---|
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | ORALKLEEN | 2022 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | ORALKLEEN | 2022 |
| Tongue ScraperLCN · Class 1 | — | Lister | Mc3 MouthEzeMc4 | 2022 |
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | ORALKLEEN | 2022 |
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 |
|---|---|---|
| ORALKLEEN LLCFDA reg. 3018418236 | Phoenix, AZ, United States | Complaint file establishment, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086130). 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.