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

KMY — Predicate Candidate Screening

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

252 daysmedian FDA review time

496 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K931615	NITE-GUIDE	ORTHO-TAIN, Inc.	1995-04-14	743
K942667	DENT-O-CRYL ORTHODONTIC ACRYLIC	Dentauraum, Inc.	1995-02-13	252
K924351	GLENROE ELASTIBITE STIMULATOR	Glenroe Technologies	1994-01-06	496
K925064	RELAX-O-GUARD	Aquatemp Service Co., Inc.	1993-09-13	342
K924975	THE ORTHOTRAINER	Myofunctional Research Corp. Pty. , Ltd.	1993-07-08	281
K924974	THE TMJ APPLIANCE	Myofunctional Research Corp. Pty. , Ltd.	1993-06-23	266
K904128	PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER	American Orthodontics	1990-11-09	65
K891328	PREFORMED TEMPLATE FOR TOOTH POSITIONER	American Orthodontics	1989-03-31	21
K833455	REMOLDABLE CRANIOMANDIBULAR APPLIANCE	Jeffrey H. Attlin	1984-01-10	105
K831793	AQUALIZER MOUTHPIECE	Martin D. Lerman	1983-08-12	70
K821458	DYNAMIC FUNTIONAL POSITIONER	Dynamic Functional Positioner, Inc.	1982-06-09	33
K780619	PREFORMED TOOTH POSITIONER	Tp Laboratories, Inc.	1978-06-28	76

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