FDA Registration
Active
🇺🇸 United States
ISONIC INC.
Reg #: 3011774865
·
FEI: 3011774865
·
Expires 2026
Products
9
Proprietary Names
9
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- ISONIC INC.
- Registration Number
- 3011774865
- FEI Number
- 3011774865
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2243 S THROOP ST
- City
- Chicago
- State
- IL
- ZIP
- 60608
- Country
- US
Owner / Operator
- Firm Name
- iSonic Inc.
- Operator Number
- 10049874
- Address
- 2243 S. Throop St.
- City
- Chicago
- State
- IL
- Postal Code
- 60608
- Country
- US
- Correspondent
- Ten Chu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pupillometer, Manual | HLH | Class 1 | Ophthalmic | No | 2019-07-24 |
| Cleaner, Denture, Mechanical | JER | Class 1 | Dental | No | 2015-08-18 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2015-08-18 |
| Instrument, Surgical, Sonic And Accessory/Attachment | JDX | Class 2 | Orthopedic | No | 2020-02-07 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2019-07-24 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2019-07-24 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2015-08-18 |
| Battery, Replacement, Rechargeable | MOQ | Class 1 | General, Plastic Surgery | No | 2020-02-07 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2020-06-13 |
Proprietary Names
iSonic
iSonic® Ultrasonic Denture Retainer Cleaner
iSonic® Ultrasonic Cleaner
iSonic® Ultrasonic C-PAP Cleaner
iSonic, Resurge, StatClean, Z3 (Benco)
U-Smile
iSonic® Green Natural Ultrasonic Denture Cleanser
iSonic® White Ultrasonic Denture Cleanser
iSonic® AlignClean Ultrasonic Cleaning Tablet
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Remanufacture Medical Device