Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Parkell — Predicate Candidate Screening

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

80 daysmedian FDA review time

128 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K923867	METAFIL	Parkell	1992-10-06	64
K905032	MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL	Parkell	1991-03-15	128
K900303	CONNECT	Parkell	1990-04-12	80
K896719	PRIMER-P ADHESIVE AGENT	Parkell	1990-02-22	85
K895750	HEMA-PRIMER	Parkell	1989-12-21	86
K892003	ABRAKADABRA - DENTAL ADHESIVE SYSTEM	Parkell	1989-06-07	71
K884918	PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER	Parkell	1989-02-13	77
K881914	COVER UP	Parkell	1988-07-15	67

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