Data / Medical devices / Italy / Micerium S.P.A.

Micerium S.P.A.: FDA-registered device maker in AVEGNO Genova, Italy, 5 510(k) clearances

Name: Micerium S.P.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Micerium S.P.A. is registered with the FDA (registration 3004130302) in AVEGNO Genova, Italy. It lists 17 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 7, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004130302
Address: Via G. Marconi 83, AVEGNO Genova, Italy, 16036
Owner or operator: MICERIUM S.P.A. (9091082)
Roles: Manufacturer
First device listed: November 28, 2006
Registered through: 2026
Brand names listed: Amcop Bioactivator, ELASTOOSAS, ENA, ENA BOND, ENA CEM, ENA CEM HF, ENA CEM HV, ENA ETCH and more

Devices it lists

Device	Product code	Class	Role	Source
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Manufacturer	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Cement, Dental	EMA	2	Manufacturer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Manufacturer	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Manufacturer	accessdata.fda.gov
Curette, Periodontic	EMS	1	Manufacturer	accessdata.fda.gov
Disk, Abrasive	EHJ	1	Manufacturer	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Manufacturer	accessdata.fda.gov
Point, Abrasive	EHL	1	Manufacturer	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Manufacturer	accessdata.fda.gov
Post, Root Canal	ELR	1	Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Manufacturer	accessdata.fda.gov
Strip, Polishing Agent	EHM	1	Manufacturer	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Manufacturer	accessdata.fda.gov
Wheel, Polishing Agent	EJQ	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 7, 2011	K103474	ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)	EBG	Substantially Equivalent	Micerium S.P.A.	accessdata.fda.gov
January 17, 2008	K072978	TENDER ORTHO BOND-ENA BOND-ENA ETCH	DYH	Substantially Equivalent	Micerium S.P.A.	accessdata.fda.gov
January 12, 2007	K063170	TENDER FIBER	EBI	Substantially Equivalent	Micerium S.P.A.	accessdata.fda.gov
December 27, 2006	K062355	ENA CEM	EMA	Substantially Equivalent	Micerium S.P.A.	accessdata.fda.gov
November 17, 2006	K062906	ENA HFO COMPOSITE SYSTEM	EBF	Substantially Equivalent	Micerium S.P.A.	accessdata.fda.gov

Compare with other makers

Updated February 7, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.