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

EHP · Predicate Candidate Screening

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

67 daysmedian FDA review time

198 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K022032	ACETAL	Inovativ, LLC	2002-08-29	69
K983558	ACETAL DENTAL/PREFORMED CLASP	Dentamax, Inc.	1999-01-07	86
K974622	DENTAL D	Micro Dental Laboratories	1998-02-10	61
K954971	ACETAL DENTAL/PREFORMED CLASP	B & H Technical Services , Ltd.	1995-12-11	45
K955946	ACETAL DENTAL/PREFORMED CLASP	Pressing DI Monticelli Rag. Stefano	1995-12-11	45
K854765	INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH	C&C Systems, Inc.	1986-06-13	198
K800575	VACUDENT LUMIX 70	Vacudent Sales Corp.	1980-05-20	67
K800574	VACUDENT LUMIX 65	Vacudent Sales Corp.	1980-05-20	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