FDA Registration
Active
🇮🇹 Italy
DENTAL MANUFACTURING SPA
Reg #: 3001389926
·
FEI: 3001389926
·
Expires 2026
Products
6
Proprietary Names
15
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- DENTAL MANUFACTURING SPA
- Registration Number
- 3001389926
- FEI Number
- 3001389926
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Ca Mignola Nuova, 1699
- City
- Badia Polesine Rovigo
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K201827
Owner / Operator
- Firm Name
- DENTAL MANUFACTURING SPA
- Operator Number
- 10061948
- Address
- Via Ca Mignola Nuova, 1699
- City
- Badia Polesine
- State
- Rovigo
- Postal Code
- 45021
- Country
- IT
- Correspondent
- Irma Piazza
US Agent
- Business Name
- THEMA CORP
- Contact Name
- Silvia Tamarri
- Address
- 2929 Arch Street
- City
- Philadelphia
- State
- PA
- ZIP
- 19104
- Country
- US
- [email protected]
- Phone
- 215 8459459
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2025-07-14 |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2025-07-14 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2025-07-14 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2025-07-14 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2025-07-14 |
| Plate, Base, Shellac | EEA | Class 1 | Dental | No | 2025-07-14 |
Proprietary Names
ACRY PRINT 3D RU-001 TEMPORARY
ACRY NATURE AFG 8 UPPER
ACRY SMART
ACRY PLUS
ACRY PLUS V
ACRY SMART DIGITAL 6 LOWER
ACRY SMART DIGITAL 8 LOWER
ACRY SMART DIGITAL 8 UPPER
ACRY SMART DIGITAL 6 UPPER
ACRY NATURE AFG 8 LOWER
ACRY NATURE AFG 6 LOWER
ACRY NATURE AFG 6 UPPER
ACRY PRINT 3D RU-004 DENTURE HI
ACRY PRINT 3D RU-005 GUIDE
ACRY PRINT 3D RU-003 TRY-IN
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device