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

Zhermack Dental Production · Predicate Candidate Screening

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

315 daysmedian FDA review time

696 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K935892	INDURENT GEL	Zhermack Dental Production	1995-10-17	735
K935890	ZETAPLUS (PUTTY)	Zhermack Dental Production	1995-09-08	696
K935898	HYDROGUM	Zhermack Dental Production	1995-08-22	679
K935896	THIXOFLEX	Zhermack Dental Production	1994-09-09	332
K935885	ELITE FAST PUTTY SOFT	Zhermack Dental Production	1994-08-23	315
K935888	ELITE FAST LIGHT BODY	Zhermack Dental Production	1994-08-23	315
K935886	ELITE LIGHT BODY	Zhermack Dental Production	1994-08-23	315
K931242	ELITE PUTTY HARD	Zhermack Dental Production	1994-08-23	530
K935884	ELITE PUTTY SOFT	Zhermack Dental Production	1994-08-23	315
K935887	ELITE REGULAR BODY	Zhermack Dental Production	1994-08-23	315
K935889	OCCLUFAST	Zhermack Dental Production	1994-08-23	315

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