Manufacturer registered with FDA
Micerium S.P.A.
AVEGNO (GE), Italy. Lists 17 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 17
- Brands and models
- 46
- 510(k) clearances
- 62006–2011
- Markets registered in
- 13225 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2000–2026
Registered in 13 markets
Where regulators' registries name Micerium S.P.A. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Micerium S.P.A. | 6 clearances | 2006–2011 | Below |
| European Union | EUDAMED | Registration holder | Micerium S.p.A. | 82 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | MICERIUM S.P.A. | 50 | 2006–2023 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Micerium S.p.A. | 23 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MICERIUM S.P.A | 21 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Micerium S.p.A.MICERIUM S.p.A. | 16 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | MICERIUM S.p.AMicerium S.P.A · Micerium S.p.A · +1 | 8 | 2006–2011 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MICERIUM S.p.A. | 7 | 2018–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MICERIUM S.P.A | 7 | 2015–2021 | Pure Global AI |
| Australia | TGA | Manufacturer | Micerium SpA | 4 | 2022–2025 | Pure Global AI |
| China | NMPA | Registration holder | 美塑股份有限公司MICERIUM S.P.A. | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MICERIUM S.P.A. | 2 | 2011–2017 | Pure Global AI |
| Israel | AMAR | Manufacturer | MICERIUM SPAMicerium S.P.A | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Micerium S.P.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | ENA BONDENA ETCHEna SealTENDER ORTHO BOND | 2008 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | ENA CEM HVENA FLOWENA HFOENA HRiENA HRi FlowENA SHINYENA TENDERUniversal 1 | 2006 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | ENA TEMPENAMEL PLUS TEMP | 2013 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | TENDER FIBER DUETENDER FIBER ORTHOTENDER FIBER QUATTRO | 2006 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Ena Care 3E Interdental BrushEna Care TBEna White 2 | 2015 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | ENA SHINY | 2008 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Ena Oral Care Smart Prophy Brushes and Polishers | 2019 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | ENA SHINY | 2008 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | ENA SHINY | 2008 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | ENAENA MATRIX Sectional Matrix SystemMAS Gingival protectionMAS Surgical guideMonkey - HookPin-HookShinyTEMPTPEN | 2009 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | drill for locking systemMAS Ball BurMAS DrillPilot ball bur | 2009 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | ENA SHINY | 2008 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Ena Oral Care Smart Prophy PasteENA SHINY | 2008 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | ENA POST | 2008 |
| Dental CementEMA · Class 2 | Dental cements | Maker | ENA CEMENA CEM HF | 2006 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | Ena Oral Care Easy Curette | 2019 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Amcop BioactivatorELASTOOSAS | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Micerium S.P.A. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 7 Feb 2011 | K103474 | ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) | EBG Resin Temporary Crown and Bridge |
| 17 Jan 2008 | K072978 | TENDER ORTHO BOND-ENA BOND-ENA ETCH | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 12 Jan 2007 | K063170 | TENDER FIBER | EBI Rebasing Repairing Relining Denture Resin |
| 27 Dec 2006 | K062355 | ENA CEM | EMA Dental Cement |
| 8 Dec 2006 | K062367 | MINISCREWS ANCHORING SYSTEM, M.A.S. | DZE Root-Form Endosseous Implant |
| 17 Nov 2006 | K062906 | ENA HFO COMPOSITE SYSTEM | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MICERIUM S.P.A.FDA reg. 3004130302 | AVEGNO Genova, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9091082). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.