Manufacturer registered with FDA
Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece
Wilmington, DE, United States. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece 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 Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Fluid-Filled Teething RingKKO · Class 2 | — | Maker | Chemo Mouthpiece(TM)Denta-Cool(TM)Ice Cold Mouthpiece(TM) | 2018 |
| Intraoral Cooling DeviceQUA · Class 2 | — | Maker | Chemo Mouthpiece | 2024 |
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
Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece 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: Chemo Mouthpiece, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Jan 2024 | K232917 | Chemo Mouthpiece | Chemo Mouthpiece, LLC | QUA Intraoral Cooling Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ChemoMouthpiece, LLC D/B/A Ice Cold MouthpieceFDA reg. 3015177652 | Wilmington, DE, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058983). 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.