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

The Hygenic Corp. — Predicate Candidate Screening

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

111 daysmedian FDA review time

233 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K954990	DENTAL DAM	The Hygenic Corp.	1996-01-26	87
K930764	ENDO-ICE-PULP TESTER-THERMAL	The Hygenic Corp.	1993-05-27	104
K905418	GATES GLIDDEN DRILLS	The Hygenic Corp.	1991-07-25	233
K911225	TRAY DOUGH	The Hygenic Corp.	1991-04-17	27
K905640	SOLID CORE GUTTA PERCHA CARRIER	The Hygenic Corp.	1991-03-05	78
K900301	NOVUS BONDING AGENT	The Hygenic Corp.	1990-05-15	113
K900844	WEDJETS	The Hygenic Corp.	1990-04-16	53
K894092	DENTAL ENDODONTIC CEMENT (MODIFICATION)	The Hygenic Corp.	1990-01-10	216
K881826	ENDO-ICE	The Hygenic Corp.	1988-08-23	116
K873644	PULP PEN	The Hygenic Corp.	1987-10-27	48
K863393	ENDOCATER	The Hygenic Corp.	1987-06-11	281
K854529	INLAY WAX REGULAR	The Hygenic Corp.	1986-03-10	117
K854527	STICKY WAX	The Hygenic Corp.	1986-03-04	111
K854530	PREMIUM FLEXI-TOUGH	The Hygenic Corp.	1986-03-04	111
K850863	ULTRAFIL-LT (GUTTA PERCHA)	The Hygenic Corp.	1985-04-16	46
K791970	HYGENIC RUBBER DAM LUBRICANT	The Hygenic Corp.	1979-11-16	45

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