Zhermack S.p.A.
BADIA POLESINE (RO) Rovigo, IT
ZHERMACK S.P.A. appears in FDA device records in BADIA POLESINE (RO) Rovigo, IT. FDA records list 19 510(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 19 510(k) clearances for Zhermack S.p.A. between 1996 and 2009. The busiest year on record is 2002, with 3. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 2 |
| 2002 | 3 |
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 3 |
| 2008 | 2 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K083739 | HYDRORISE AND HYDROSYSTEM | ELW | Substantially Equivalent | |
| K081084 | COLORISE RIGID | ELW | Substantially Equivalent | |
| K080130 | OCCLUFAST CAD | ELW | Substantially Equivalent | |
| K073005 | ELITE GLASS | ELW | Substantially Equivalent | |
| K070677 | COLORISE | ELW | Substantially Equivalent | |
| K070700 | FREEALGIN | ELW | Substantially Equivalent | |
| K053619 | COLORBITE | ELW | Substantially Equivalent | |
| K050417 | ELITE IMPLANT | ELW | Substantially Equivalent | |
| K051424 | HYDROGUM 5 | ELW | Substantially Equivalent | |
| K043118 | HYDROGUM SOFT | ELW | Substantially Equivalent | |
| K043131 | TORPICALGIN | ELW | Substantially Equivalent | |
| K024041 | ZETAPLUS SOFT | ELW | Substantially Equivalent | |
| K024034 | OCCLUFAST ROCK | ELW | Substantially Equivalent | |
| K022653 | ELITE MONOPHASE | ELW | Substantially Equivalent | |
| K981091 | NEOCOLLOID, ORTHOPRINT | ELW | Substantially Equivalent | |
| K974704 | HYDROGUM | ELW | Substantially Equivalent | |
| K972239 | ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING | ELW | Substantially Equivalent | |
| K972027 | ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) | ELW | Substantially Equivalent | |
| K963609 | PHASE PLUS | ELW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9614794 | 3003762341 | ZHERMACK S.P.A. | VIA BOVAZECCHINO, 100, BADIA POLESINE (RO) Rovigo 45021 IT | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain