FDA 510(k) Applications for Medical Device Product Code "DZM"
(Needle, Dental)

FDA 510(k) Number Applicant Device Name Decision Date
K820568 A COMPANY, INC. MUSCLE DYSFUNCTION MONITOR 04/09/1982
K914562 ASEPTIC DENTAL TECHNOLOGIES, INC. ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM 03/09/1992
K896219 AUSMEDICS PTY LTD. SAFE-T-CAP "NEEDLE COVER" 01/22/1990
K870921 CHURCHILL CORP. DENTAL NEEDLE (CARTRIDGE TYPE) 04/03/1987
K920758 DENTSPLY INTL. JENKER NEEDLE STICK PROTECTOR 04/28/1992
K861150 EXEL INTL. EXEL DENTAL NEEDLE 04/11/1986
K910446 FAIRFAX DENTAL, INC. STABIDENT LOCAL ANESTHESIA SYSTEM 06/03/1991
K910475 HEALTH TECHNOLOGY SYSTEMS, INC. DENTAL NEEDLE PROTECTIVE SYSTEM 09/13/1991
K894373 PHARMA-PLAST USA, INC. NIPRO DENTAL NEEDLE 10/13/1989
K990511 SCHIFF & CO. X-TIP INTRAOSSEOUS PERFORATOR 04/27/1999
K802811 SHERWOOD MEDICAL CO. MONOJECT ROOT CANAL FILLING MAT. NEEDLE 11/24/1980
K833304 SMITH & NEPHEW, MPL DIVISION HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST 03/30/1984
K761206 SMITH & NEPHEW, MPL DIVISION INTEROSSEOUS NEEDLE 12/13/1976
K913573 SPECIALITES SEPTODONT SAFETY PLUS DENTAL INJECTION NEEDLE 11/07/1991
K851524 SPECIALITES SEPTODONT SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE 09/23/1985
K864970 TERUMO MEDICAL CORP. TERUMO DENTAL NEEDLES 03/10/1987


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