Micerium S.p.A.
AVEGNO Genova, IT
MICERIUM S.P.A. appears in FDA device records in AVEGNO Genova, IT. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Micerium S.p.A. between 2006 and 2011. The busiest year on record is 2006, with 3. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103474 | ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) | EBG | Substantially Equivalent | |
| K072978 | TENDER ORTHO BOND-ENA BOND-ENA ETCH | DYH | Substantially Equivalent | |
| K063170 | TENDER FIBER | EBI | Substantially Equivalent | |
| K062355 | ENA CEM | EMA | Substantially Equivalent | |
| K062367 | MINISCREWS ANCHORING SYSTEM, M.A.S. | DZE | Substantially Equivalent | |
| K062906 | ENA HFO COMPOSITE SYSTEM | EBF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004130302 | 3004130302 | MICERIUM S.P.A. | VIA G. MARCONI 83, AVEGNO Genova 16036 IT | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- EJRAgent, Polishing, Abrasive, Oral Cavity
- EJLBur, Dental
- EMACement, Dental
- EBGCrown And Bridge, Temporary, Resin
- EHKCup, Prophylaxis
- EMSCurette, Periodontic
- EHJDisk, Abrasive
- EJBHandle, Instrument, Dental
- DZEImplant, Endosseous, Root-Form
- EBFMaterial, Tooth Shade, Resin
- EHLPoint, Abrasive
- KMYPositioner, Tooth, Preformed
- ELRPost, Root Canal
- EBIResin, Denture, Relining, Repairing, Rebasing
- EHMStrip, Polishing Agent
- EFWToothbrush, Manual
- EJQWheel, Polishing Agent
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain