Not currently registered with FDA under this name
Chemo Mouthpiece, LLC
Closter, NJ, United States. Named as applicant on 1 dental 510(k) clearance between 2024 and 2024. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12024–2024
- Markets registered in
- 68 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Chemo Mouthpiece, LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Chemo Mouthpiece, LLC | 1 clearances | 2024–2024 | Below |
| Australia | TGA | Manufacturer | Chemo Mouthpiece LLCChemoMouthpiece LLC | 2 | 2019–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CHEMO MOUTHPIECE, LLCCHEMOMOUTHPIECE, LLC | 2 | 2020–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CHEMOMOUTHPIECE LLC | 2 | 2019–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | Chemo Mouthpiece, LLC | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Chemo Mouthpiece LLC | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Chemo Mouthpiece, LLC as the applicant.
Some of these clearances are listed with FDA today by another company: Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece (1).
Sources
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 of the most recent filing, which can be a US agent.