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

EFH — Predicate Candidate Screening

10 FDA 510(k) clearances under this product code; the 50 most recent screened below.

76 daysmedian FDA review time

217 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K965026	PFINGST PRESSURE PASTE	Pfingst & Co., Inc.	1997-02-10	55
K912632	OCCLUDE	Pascal Co., Inc.	1992-01-17	217
K911259	HYDENT	Pascal Co., Inc.	1991-06-06	76
K864572	FIXTECTOR	Prodent Intl., Inc.	1987-02-12	84
K870032	REVISED T-SCAN SYSTEM	Sentek, Inc.	1987-02-02	28
K832647	ARTICULATING PAPER	Ardent Intl., Inc.	1984-02-21	200
K833132	MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY	Myo-Tronics Research, Inc.	1984-02-10	150
K810498	CENTRIC (BITE) REGISTRATION PASTE	Wallace A. Erickson & Co.	1981-03-17	21
K771011	ARTICULATING PAPER	Parker Laboratories, Inc.	1977-06-20	14
K770492	CRACK DETECTOR, DEN-MAT	Dey-Mat, Inc.	1977-03-21	7

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