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
- [email protected]
- Phone
- 888 5828115
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2019-05-09 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2008-02-01 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2006-11-28 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2009-03-13 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2008-02-01 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2015-04-22 |
| Curette, Periodontic | EMS | Class 1 | Dental | No | 2019-05-09 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2006-11-28 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2008-01-29 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2022-02-14 |
| Point, Abrasive | EHL | Class 1 | Dental | No | 2008-02-01 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 2008-02-01 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2006-11-28 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2008-02-01 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2013-06-24 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2008-02-01 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2009-03-13 |
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