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

KMT · Predicate Candidate Screening

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

39 daysmedian FDA review time

225 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K031809	PERIO PROTECT TRAY	Perio Protect, LLC	2004-01-23	225
K904914	DENTAL VACUUM INJECTION TRAY	The Lebanon Vac-Tray Corp.	1990-12-17	47
K871784	TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI	Colgate-Hoyt Laboratories	1987-05-27	21
K853882	SUPER SLICK	Tang Products	1985-11-18	60
K820104	NUPRO* GEL TRAY	Johnson & Johnson Professionals, Inc.	1982-02-23	39
K811154	HOYT ECONO-TRAY	Hoyt Laboratories	1981-05-13	15
K780712	KERR DISCOVERY DISPOSABLE FLUORIDE TRAY	Kerr Corporation (Danbury)	1978-05-17	21
K770064	FLUORIDE GEL DISPOSABLE TRAY	Lorvic Corp.	1977-01-14	3

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