FDA Registration
Active
🇺🇸 United States
ISMILE DENTAL PRODUCTS INC.
Reg #: 3007046497
·
FEI: 3007046497
·
Expires 2026
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ISMILE DENTAL PRODUCTS INC.
- Registration Number
- 3007046497
- FEI Number
- 3007046497
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4201 SIERRA POINT DR STE 102
- City
- Sacramento
- State
- CA
- ZIP
- 95834
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172280
Owner / Operator
- Firm Name
- iSmile Dental Products, Inc.
- Operator Number
- 10052362
- Address
- 4201 Sierra Point Drive, Ste 102
- City
- Sacramento
- State
- CA
- Postal Code
- 95834
- Country
- US
- Correspondent
- Bryan Shields
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2023-05-03 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2023-05-03 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2023-05-03 |
| Material, Impression | ELW | Class 2 | Dental | No | 2016-07-20 |
Proprietary Names
iSmile Dental Products
Establishment Types
Repack or Relabel Medical Device