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

JEX · Predicate Candidate Screening

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

50 daysmedian FDA review time

95 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K955242	TITANIUM BIRD BEAK PLIER	Sybron Dental Specialties, Inc.	1995-12-01	16
K935141	DENTAURUM PLIERS	Dentauraum, Inc.	1994-01-31	95
K924645	TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS	Unitek Corp.	1992-11-25	72
K924295	DEBRACKETING INSTRUMENT	Unitek Corp.	1992-11-23	89
K854088	UNITEK LIFT-OFF DEBRACKETING INSTRUMENT	Unitex Corp.	1985-11-26	50
K843742	UNITEK CONVERTIBLE CAP REMOVER TOOL	Unitek Corp.	1984-11-09	45
K760984	ORTHODONTIC INSTRUMENTS	Adp Intl., Inc.	1976-11-15	25

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