Data / Medical devices / United States / ChemoMouthpiece, LLC D/B/A Ice Cold Mouthpiece
ChemoMouthpiece, LLC D/B/A Ice Cold Mouthpiece: FDA-registered device maker in Wilmington, DE, United States, 1 510(k) clearance
ChemoMouthpiece, LLC D/B/A Ice Cold Mouthpiece is registered with the FDA (registration 3015177652) in Wilmington, DE, United States. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 23, 2024. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015177652
- Address
- 3411 Silverside Rd Ste 248, Wilmington, DE, United States, 19810
- Owner or operator
- Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece (10058983)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 17, 2018
- Registered through
- 2027
- Brand names listed
- Chemo Mouthpiece(TM), Chemo Mouthpiece, Denta-Cool(TM), Ice Cold Mouthpiece(TM)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Ice | KYR | 1 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Complaint file establishment | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Excavator, Dental, Operative | EKC | 1 | Complaint file establishment | accessdata.fda.gov |
| Instrument, Cutting, Operative | EKD | 1 | Complaint file establishment | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Complaint file establishment | accessdata.fda.gov |
| Intraoral Cooling Device | QUA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Complaint file establishment | accessdata.fda.gov |
| Ring, Teething, Fluid-Filled | KKO | 2 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Syringe, Irrigating (Dental) | EIB | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 23, 2024 | K232917 | Chemo Mouthpiece | QUA | Substantially Equivalent | Chemo Mouthpiece, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Intraoral Cooling Device
- All makers of Elevator, Surgical, Dental
- All makers of Syringe, Irrigating (Dental)
- All makers of Chisel, Bone, Surgical
- All makers of Instruments, Dental Hand
- All makers of Ring, Teething, Fluid-Filled
Updated January 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.