FDA Registration
Active
🇺🇸 United States
ChemoMouthpiece, LLC D/B/A Ice Cold Mouthpiece
Reg #: 3015177652
·
FEI: 3015177652
·
Expires 2026
Products
10
Proprietary Names
4
Establishment Types
4
Classifications
10
Registration Details
- Registration Name
- ChemoMouthpiece, LLC D/B/A Ice Cold Mouthpiece
- Registration Number
- 3015177652
- FEI Number
- 3015177652
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3411 Silverside Rd Ste 248
- City
- Wilmington
- State
- DE
- ZIP
- 19810
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232917
Owner / Operator
- Firm Name
- Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece
- Operator Number
- 10058983
- Address
- 3411 Silverside Road, Suite 248
- City
- Wilmington
- State
- DE
- Postal Code
- 19810
- Country
- US
- Correspondent
- David Yoskowitz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2020-08-28 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2020-08-28 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2020-08-28 |
| Instrument, Cutting, Operative | EKD | Class 1 | Dental | No | 2020-08-28 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2020-08-28 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2018-11-17 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2020-08-28 |
| Syringe, Irrigating (Dental) | EIB | Class 1 | Dental | No | 2020-08-28 |
| Intraoral Cooling Device | QUA | Class 2 | Dental | No | 2024-03-07 |
| Ring, Teething, Fluid-Filled | KKO | Class 2 | Dental | No | 2018-11-17 |
Proprietary Names
Denta-Cool(TM)
Ice Cold Mouthpiece(TM)
Chemo Mouthpiece(TM)
Chemo Mouthpiece
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device