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

Espe-Premier Sales Co. — Predicate Candidate Screening

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

35 daysmedian FDA review time

35 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K812116	PERMAGUM	Espe-Premier Sales Co.	1981-08-31	35
K812119	NIMETIC-DISPERS	Espe-Premier Sales Co.	1981-08-31	35
K812118	NIMETIC POLISHING PASTE	Espe-Premier Sales Co.	1981-08-31	35
K812117	PERMAGUM ADHESIVE	Espe-Premier Sales Co.	1981-08-31	35
K812115	KETAC-CHEM	Espe-Premier Sales Co.	1981-08-31	35
K811624	VISIO-SEAL	Espe-Premier Sales Co.	1981-06-26	17
K810265	VISIO-BAND	Espe-Premier Sales Co.	1981-02-23	21
K810266	ETCHING GEL	Espe-Premier Sales Co.	1981-02-23	21
K803227	VISIO-DISPERS	Espe-Premier Sales Co.	1981-01-14	26
K803209	ELIPAR LIGHT SOURCE	Espe-Premier Sales Co.	1981-01-14	27

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