Micerium S.P.A.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Micerium S.P.A.” (first 2006, latest 2011), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (6)
Most recent Micerium S.P.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103474 | ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) | EBG | 2011-02-07 | 73 |
| K072978 | TENDER ORTHO BOND-ENA BOND-ENA ETCH | DYH | 2008-01-17 | 87 |
| K063170 | TENDER FIBER | EBI | 2007-01-12 | 86 |
| K062355 | ENA CEM | EMA | 2006-12-27 | 135 |
| K062367 | MINISCREWS ANCHORING SYSTEM, M.A.S. | DZE | 2006-12-08 | 116 |
| K062906 | ENA HFO COMPOSITE SYSTEM | EBF | 2006-11-17 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Micerium S.P.A..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Micerium S.P.A.?
FDA lists 6 510(k) clearances under the applicant name “Micerium S.P.A.” (first 2006, latest 2011), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Micerium S.P.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micerium S.P.A. is 86 days.
Which FDA product codes appear under Micerium S.P.A.?
The most frequent FDA product codes under this applicant name are DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 1); DZE (Implant, Endosseous, Root-Form, 1); EBF (Material, Tooth Shade, Resin, 1).
Next steps
- See all 6 Micerium S.P.A. clearances with predicates and recalls
- Run predicate analysis for product code DYH, Micerium S.P.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.