MICERIUM S.P.A.

FDA Device Registration & Listing · AVEGNO Genova, IT · Registration 3004130302

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
3004130302
FEI Number
3004130302
Entity Name
MICERIUM S.P.A.
City/State/Country
AVEGNO Genova, IT
Establishment Address
VIA G. MARCONI 83, AVEGNO Genova 16036, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MICERIUM S.P.A. (Owner Number: 9091082)
Owner / Operator Contact Address
VIA MARCONI 83, --, AVEGNO (GE), IT-GE 16036, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Ena Oral Care Smart Prophy Brushes and Polishers ENA SHINY Ena Oral Care Smart Prophy Paste ENA CEM HF ENA CEM MAS Drill MAS Ball Bur drill for locking system Pilot ball bur ENA SHINY Ena Care TB Ena Care 3E Interdental Brush Ena White 2 Ena Oral Care Easy Curette ENA FLOW Universal 1 ENA HRi ENA TENDER ENA HFO ENA SHINY ENA HRi Flow ENA CEM HV ENA BOND ENA ETCH TENDER ORTHO BOND Ena Seal ELASTOOSAS Amcop Bioactivator ENA SHINY ENA SHINY TENDER FIBER QUATTRO TENDER FIBER DUE TENDER FIBER ORTHO ENA POST

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EHK Cup, Prophylaxis Dental Class 1 872.6290 2019-05-09
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2008-02-01
EMA Cement, Dental Dental Class 2 872.3275 2006-11-28
EJL Bur, Dental Dental Class 1 872.3240 2009-03-13
EHM Strip, Polishing Agent Dental Class 1 872.6010 2008-02-01
EFW Toothbrush, Manual Dental Class 1 872.6855 2015-04-22
EMS Curette, Periodontic Dental Class 1 872.4565 2019-05-09
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2006-11-28
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2008-01-29
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2022-02-14
EHL Point, Abrasive Dental Class 1 872.6010 2008-02-01
EJQ Wheel, Polishing Agent Dental Class 1 872.6010 2008-02-01
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2006-11-28
ELR Post, Root Canal Dental Class 1 872.3810 2008-02-01

Official Correspondent

EUGENIO MICELI

US Agent Details

Patrizia Manna Business: Synca Direct Email: patrizia.m@synca.com Phone: (888) 5828115

Related Public Records

Same Entity

MICERIUM S.P.A.
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
K121698 Dentsply International, Inc. NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN 2012-08-06
K972485 Arent, Fox, Kintner, Plotkin & Kahn CIMPAT N 1997-09-08
K982895 Sterngold/Implamed STERNOMEGA COMPOMER CEMENT 1998-10-09
K033068 Voco GmbH IONOFIL COLOR AC 2003-10-31
K062064 Southern Dental Industries, Inc. RIVA BOND LC 2006-11-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

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3012312751 DENTAL BRANDS FOR LESS Markham Ontario, CA
3006847937 Premium Plus International Limited Hong Kong, HK
3014926389 Jiangsu JianYu Health Medical Co., Ltd Changzhou City Jiangsu, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004130302. Last updated year: 2026. Please use registration number 3004130302 when referencing this establishment in official correspondence.
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