Company ยท US
Zhermack S.P.A.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2009. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ELW | Material, Impression | 19 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2009 | K083739 | HYDRORISE AND HYDROSYSTEM Zhermack S.P.A. | ELW |
| May 14, 2008 | K081084 | COLORISE RIGID Zhermack S.P.A. | ELW |
| Mar 14, 2008 | K080130 | OCCLUFAST CAD Zhermack S.P.A. | ELW |
| Dec 12, 2007 | K073005 | ELITE GLASS Zhermack S.P.A. | ELW |
| May 11, 2007 | K070677 | COLORISE Zhermack S.P.A. | ELW |
| Apr 25, 2007 | K070700 | FREEALGIN Zhermack S.P.A. | ELW |
| Mar 1, 2006 | K053619 | COLORBITE Zhermack S.P.A. | ELW |
| Jul 19, 2005 | K050417 | ELITE IMPLANT Zhermack S.P.A. | ELW |
| Jul 15, 2005 | K051424 | HYDROGUM 5 Zhermack S.P.A. | ELW |
| Jan 24, 2005 | K043118 | HYDROGUM SOFT Zhermack S.P.A. | ELW |
| Dec 15, 2004 | K043131 | TORPICALGIN Zhermack S.P.A. | ELW |
| Dec 18, 2002 | K024041 | ZETAPLUS SOFT Zhermack S.P.A. | ELW |
| Dec 18, 2002 | K024034 | OCCLUFAST ROCK Zhermack S.P.A. | ELW |
| Oct 28, 2002 | K022653 | ELITE MONOPHASE Zhermack S.P.A. | ELW |
| May 21, 1998 | K981091 | NEOCOLLOID, ORTHOPRINT Zhermack S.P.A. | ELW |
| Jan 29, 1998 | K974704 | HYDROGUM Zhermack S.P.A. | ELW |
| Aug 1, 1997 | K972239 | ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING Zhermack S.P.A. | ELW |
| Jul 16, 1997 | K972027 | ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) Zhermack S.P.A. | ELW |
| Nov 14, 1996 | K963609 | PHASE PLUS Zhermack S.P.A. | ELW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||