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510(k) K894373

Device
NIPRO DENTAL NEEDLE
Applicant
PHARMA-PLAST USA, INC.
510(k) number
K894373
Product code
DZM  
Decision
Substantially Equivalent (SESE)
Decision date
1989-10-13
Date received
1989-07-17
Regulation
872.4730
Classification name
Needle, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LINDEMANN, BOC
Address
26133 Us 19 N Clearwater FL US 34623 34623

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DZM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K990511X-TIP INTRAOSSEOUS PERFORATORSchiff & Co.1999-04-27
K920758JENKER NEEDLE STICK PROTECTORDentsply Intl.1992-04-28
K914562ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEMAseptic Dental Technologies, Inc.1992-03-09
K913573SAFETY PLUS DENTAL INJECTION NEEDLESpecialites Septodont1991-11-07
K910475DENTAL NEEDLE PROTECTIVE SYSTEMHealth Technology Systems, Inc.1991-09-13
K910446STABIDENT LOCAL ANESTHESIA SYSTEMFairfax Dental, Inc.1991-06-03
K896219SAFE-T-CAP NEEDLE COVERAusmedics Pty , Ltd.1990-01-22
K870921DENTAL NEEDLE (CARTRIDGE TYPE)Churchill Corp.1987-04-03
K864970TERUMO DENTAL NEEDLESTerumo Medical Corp.1987-03-10
K861150EXEL DENTAL NEEDLEExel Intl.1986-04-11
K851524SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLESpecialites Septodont1985-09-23
K833304HYPO BRAND DISPOS. DENTAL NEEDLES-PLASTSmith & Nephew, Mpl Division1984-03-30
K820568MUSCLE DYSFUNCTION MONITORA Company, Inc.1982-04-09
K802811MONOJECT ROOT CANAL FILLING MAT. NEEDLESherwood Medical Co.1980-11-24
K761206INTEROSSEOUS NEEDLESmith & Nephew, Mpl Division1976-12-13

Legacy Summary#

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FDA Review#

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