DENTAL MANUFACTURING SPA

FDA Device Registration & Listing · Badia Polesine Rovigo, IT · Registration 3001389926

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3001389926
FEI Number
3001389926
Entity Name
DENTAL MANUFACTURING SPA
City/State/Country
Badia Polesine Rovigo, IT
Establishment Address
Via Ca Mignola Nuova, 1699, Badia Polesine Rovigo 45021, IT
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
DENTAL MANUFACTURING SPA (Owner Number: 10061948)
Owner / Operator Contact Address
Via Ca Mignola Nuova, 1699, Badia Polesine, IT-RO 45021, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K211415
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2025-07-14
PZY Additively Manufactured, Preformed, Resin Denture Tooth Dental Class 2 872.3590 2025-07-14
PZY Additively Manufactured, Preformed, Resin Denture Tooth Dental Class 2 872.3590 2019-12-05
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2025-07-14
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2025-07-14
MQC Mouthguard, Prescription Unknown Class U N/A 2025-07-14
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2025-07-14

Official Correspondent

Irma Piazza

US Agent Details

Silvia Tamarri Business: THEMA CORP Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

DENTAL MANUFACTURING SPA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K800400 Dentsply Intl. MAXUM DENTURE RESIN 1980-03-12
K033020 Cmp Industries, LLC IMPAK ACRYLIC REPAIR RESIN LIQUID 2003-12-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001389926. Last updated year: 2026. Please use registration number 3001389926 when referencing this establishment in official correspondence.
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