Atlas FDA

DZM

16 FDA 510(k) clearances · Product code

87 daysmedian time to decision
189 days90th percentile
16clearances measured

FDA profile

Official device name
Needle, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4730
Medical specialty
Dental
Adverse events (MAUDE)
2019: 31 · 2020: 16 · 2021: 41 · 2022: 35 · 2023: 34 · 2024: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
X-TIP INTRAOSSEOUS PERFORATOR (K990511)Schiff & Co.1999-04-27
JENKER NEEDLE STICK PROTECTOR (K920758)Dentsply Intl.1992-04-28
ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM (K914562)Aseptic Dental Technologies, Inc.1992-03-09
SAFETY PLUS DENTAL INJECTION NEEDLE (K913573)Specialites Septodont1991-11-07
DENTAL NEEDLE PROTECTIVE SYSTEM (K910475)Health Technology Systems, Inc.1991-09-13
STABIDENT LOCAL ANESTHESIA SYSTEM (K910446)Fairfax Dental, Inc.1991-06-03
SAFE-T-CAP NEEDLE COVER (K896219)Ausmedics Pty , Ltd.1990-01-22
NIPRO DENTAL NEEDLE (K894373)Pharma-Plast USA, Inc.1989-10-13
DENTAL NEEDLE (CARTRIDGE TYPE) (K870921)Churchill Corp.1987-04-03
TERUMO DENTAL NEEDLES (K864970)Terumo Medical Corp.1987-03-10
EXEL DENTAL NEEDLE (K861150)Exel Intl.1986-04-11
SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE (K851524)Specialites Septodont1985-09-23
HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST (K833304)Smith & Nephew, Mpl Division1984-03-30
MUSCLE DYSFUNCTION MONITOR (K820568)A Company, Inc.1982-04-09
MONOJECT ROOT CANAL FILLING MAT. NEEDLE (K802811)Sherwood Medical Co.1980-11-24
INTEROSSEOUS NEEDLE (K761206)Smith & Nephew, Mpl Division1976-12-13

Track DZM automatically

Every clearance here is in the API, with alerts when new ones post.