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
Phone
215 8459459

Products

Device Name Product Code
Crown And Bridge, Temporary, Resin EBG
Additively Manufactured, Preformed, Resin Denture Tooth PZY
Resin, Denture, Relining, Repairing, Rebasing EBI
Mouthguard, Prescription MQC
Positioner, Tooth, Preformed KMY
Plate, Base, Shellac EEA

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