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

DZM — Predicate Candidate Screening

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

87 daysmedian FDA review time

189 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K990511	X-TIP INTRAOSSEOUS PERFORATOR	Schiff & Co.	1999-04-27	68
K920758	JENKER NEEDLE STICK PROTECTOR	Dentsply Intl.	1992-04-28	69
K914562	ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM	Aseptic Dental Technologies, Inc.	1992-03-09	146
K913573	SAFETY PLUS DENTAL INJECTION NEEDLE	Specialites Septodont	1991-11-07	87
K910475	DENTAL NEEDLE PROTECTIVE SYSTEM	Health Technology Systems, Inc.	1991-09-13	219
K910446	STABIDENT LOCAL ANESTHESIA SYSTEM	Fairfax Dental, Inc.	1991-06-03	140
K896219	SAFE-T-CAP NEEDLE COVER	Ausmedics Pty , Ltd.	1990-01-22	87
K894373	NIPRO DENTAL NEEDLE	Pharma-Plast USA, Inc.	1989-10-13	88
K870921	DENTAL NEEDLE (CARTRIDGE TYPE)	Churchill Corp.	1987-04-03	29
K864970	TERUMO DENTAL NEEDLES	Terumo Medical Corp.	1987-03-10	78
K861150	EXEL DENTAL NEEDLE	Exel Intl.	1986-04-11	16
K851524	SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE	Specialites Septodont	1985-09-23	160
K833304	HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST	Smith & Nephew, Mpl Division	1984-03-30	189
K820568	MUSCLE DYSFUNCTION MONITOR	A Company, Inc.	1982-04-09	38
K802811	MONOJECT ROOT CANAL FILLING MAT. NEEDLE	Sherwood Medical Co.	1980-11-24	17
K761206	INTEROSSEOUS NEEDLE	Smith & Nephew, Mpl Division	1976-12-13	6

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