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

Pemaco, Inc. — Predicate Candidate Screening

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

61 daysmedian FDA review time

187 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K910676	INTRAORAL DENTAL WAX	Pemaco, Inc.	1991-08-21	187
K895562	PEMACO 2000 INTRAORAL DENTAL WAX	Pemaco, Inc.	1989-11-06	61
K895561	PEMACO 3000 INTRAORAL DENTAL WAX	Pemaco, Inc.	1989-11-06	61
K895563	PEMACO BITE WAX SHEETS	Pemaco, Inc.	1989-11-06	61
K895566	PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT	Pemaco, Inc.	1989-11-06	61
K895564	PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD	Pemaco, Inc.	1989-11-06	61
K895565	PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD	Pemaco, Inc.	1989-10-24	48

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