FDA Registration
Active
🇺🇸 United States
SWEDENT DENTAL WHOLESALE GROUP
Reg #: 3019381139
·
FEI: 3019381139
·
Expires 2026
Products
9
Proprietary Names
0
Establishment Types
1
Classifications
9
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Registration Details
- Registration Name
- SWEDENT DENTAL WHOLESALE GROUP
- Registration Number
- 3019381139
- FEI Number
- 3019381139
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1675 N Freedom Blvd STE 9B2
- City
- Provo
- State
- UT
- ZIP
- 84604
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181900
Owner / Operator
- Firm Name
- Swedent Dental Wholesale Group
- Operator Number
- 10081704
- Address
- 4066 S 4000 W
- City
- West Valley
- State
- UT
- Postal Code
- 84120
- Country
- US
- Correspondent
- Bongkoog Noh
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bur, Dental | EJL | Class 1 | Dental | No | 2021-05-10 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2021-05-10 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2021-05-10 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2021-05-10 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2021-05-10 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2021-05-10 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2021-05-10 |
| Eraser, Dental Stain | MAU | Class 1 | Dental | No | 2021-05-10 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2021-05-10 |
Establishment Types
Repack or Relabel Medical Device