Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Zhermack S.P.A. — Predicate Candidate Screening

19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

49 daysmedian FDA review time

100 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K083739	HYDRORISE AND HYDROSYSTEM	Zhermack S.P.A.	2009-03-26	100	0
K081084	COLORISE RIGID	Zhermack S.P.A.	2008-05-14	28	0
K080130	OCCLUFAST CAD	Zhermack S.P.A.	2008-03-14	56	0
K073005	ELITE GLASS	Zhermack S.P.A.	2007-12-12	49	0
K070677	COLORISE	Zhermack S.P.A.	2007-05-11	60	0
K070700	FREEALGIN	Zhermack S.P.A.	2007-04-25	43	0
K053619	COLORBITE	Zhermack S.P.A.	2006-03-01	64	0
K050417	ELITE IMPLANT	Zhermack S.P.A.	2005-07-19	151	0
K051424	HYDROGUM 5	Zhermack S.P.A.	2005-07-15	44	0
K043118	HYDROGUM SOFT	Zhermack S.P.A.	2005-01-24	75	0
K043131	TORPICALGIN	Zhermack S.P.A.	2004-12-15	33	0
K024034	OCCLUFAST ROCK	Zhermack S.P.A.	2002-12-18	12	0
K024041	ZETAPLUS SOFT	Zhermack S.P.A.	2002-12-18	12	0
K022653	ELITE MONOPHASE	Zhermack S.P.A.	2002-10-28	80	0
K981091	NEOCOLLOID, ORTHOPRINT	Zhermack S.P.A.	1998-05-21	57	0
K974704	HYDROGUM	Zhermack S.P.A.	1998-01-29	44	0
K972239	ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOF	Zhermack S.P.A.	1997-08-01	46	0
K972027	ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIAL	Zhermack S.P.A.	1997-07-16	44	2
K963609	PHASE PLUS	Zhermack S.P.A.	1996-11-14	65	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda