FDA Registration
Active
🇺🇸 United States
Preformed Denture Teeth, Partially Fabricated Denture, Partially Fabricated Partial Denture,
Reg #: 3006459726
·
FEI: 3006459726
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PREMIERE 1 DENTAL LABORATORY, L.L.C.
- Registration Number
- 3006459726
- FEI Number
- 3006459726
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 302 Manatee Avenue East, Suite 201
- City
- Bradenton
- State
- FL
- ZIP
- 34208
- Country
- US
Regulatory Submissions
- 510(k) Number
- K780722
Owner / Operator
- Firm Name
- PREMIERE 1 DENTAL LABORATORY, L.L.C.
- Operator Number
- 9106559
- Address
- 302 Manatee Avenue East, Suite 201
- City
- Bradenton
- State
- FL
- Postal Code
- 34208
- Country
- US
- Correspondent
- Domingo Hernandez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Denture Preformed (Partially Prefabricated Denture) | EKO | Class 2 | Dental | No | 2007-08-31 |
Proprietary Names
Preformed Denture Teeth, Partially Fabricated Denture, Partially Fabricated Partial Denture,
Establishment Types
Repack or Relabel Medical Device