FDA Registration Active 🇮🇹 Italy

MICERIUM S.P.A.

Reg #: 3004130302 · FEI: 3004130302 · Expires 2026
Products
17
Proprietary Names
41
Establishment Types
1
Classifications
17

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Registration Details

Registration Name
MICERIUM S.P.A.
Registration Number
3004130302
FEI Number
3004130302
Status
Active
Expiry Year
2026
Initial Importer
No
Address
VIA G. MARCONI 83
City
AVEGNO Genova
Country
IT

Regulatory Submissions

510(k) Number
K062355

Owner / Operator

Firm Name
MICERIUM S.P.A.
Operator Number
9091082
Address
VIA MARCONI 83, --
City
AVEGNO (GE)
State
Genova
Postal Code
16036
Country
IT
Correspondent
EUGENIO - MICELI

US Agent

Business Name
Synca Direct
Contact Name
Patrizia Manna
Address
1320 State Route #9
City
Champlain
State
NY
ZIP
12919
Country
US
Phone
888 5828115

Products

Device Name Product Code
Cup, Prophylaxis EHK
Agent, Polishing, Abrasive, Oral Cavity EJR
Cement, Dental EMA
Bur, Dental EJL
Strip, Polishing Agent EHM
Toothbrush, Manual EFW
Curette, Periodontic EMS
Material, Tooth Shade, Resin EBF
Adhesive, Bracket And Tooth Conditioner, Resin DYH
Positioner, Tooth, Preformed KMY
Point, Abrasive EHL
Wheel, Polishing Agent EJQ
Resin, Denture, Relining, Repairing, Rebasing EBI
Post, Root Canal ELR
Crown And Bridge, Temporary, Resin EBG
Disk, Abrasive EHJ
Handle, Instrument, Dental EJB

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 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 HRi Flow ENA CEM HV ENA BOND ENA ETCH TENDER ORTHO BOND Ena Seal ELASTOOSAS Amcop Bioactivator TENDER FIBER QUATTRO TENDER FIBER DUE TENDER FIBER ORTHO ENA POST ENA TEMP ENAMEL PLUS TEMP TPEN TEMP Shiny ENA MAS Gingival protection Pin-Hook MAS Surgical guide Monkey - Hook ENA MATRIX Sectional Matrix System

Establishment Types

Manufacture Medical Device