FDA Registration
Inactive
🇺🇸 United States
Dandy - Lehi
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Dandy - Lehi
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1320 N 300 W
- City
- Lehi
- State
- UT
- ZIP
- 84043
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170588
Owner / Operator
- Firm Name
- Zima International, Inc.
- Operator Number
- 10053996
- Address
- 11 Park Place, 3rd Floor - Suite 502
- City
- New York
- State
- NY
- Postal Code
- 10007
- Country
- US
- Correspondent
- Daniel Hanover
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-07-11 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)