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510(k) K863998

Device
COLTENE JET-MIXER
Applicant
COLTENE, INC.
510(k) number
K863998
Product code
EID  
Decision
Substantially Equivalent (SESE)
Decision date
1986-10-30
Date received
1986-10-14
Regulation
872.4565
Classification name
Syringe, Restorative And Impression Material
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BAUER, PH.D.
Address
C/O Robert Bauer & Associates 111 N. Wabash Chicago IL US 60602 60602

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EID  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K941431BONE GRAFT DELIVERY SYRINGESBio-Interfaces, Inc.1994-07-12
K913974ACCESS IMPRESSION BARRELCentrix, Inc.1992-02-25
K873153CAULK'S VPS CARTRIDGE SYSTEMDentsply Intl.1987-09-16
K871937IMPRESSION SYRINGEDentsply Intl.1987-06-05
K853282CENTRIX RIBBON TUBESCentrix, Inc.1985-08-23
K851386UNITEK DISPOSABLE IMPRESSION SYRINGEUnitek Corp.1985-04-29
K812680G-C IMPRESSION SYRINGEG-C Intl. Corp.1981-10-06
K812277PRISMA-FIL COMPULESCaulk Co., Div. Dentsply1981-09-08
K811582THE PLACERCavitron Corp.1981-07-28
K781977APPLICATOR, LEE IMPRESSIONLee Pharmaceuticals1978-12-20
K770931APPLIC SYSTEM APPLIER, ESPEEspe GmbH (Us)1977-06-03
K770941APPLIC SYSTEM ACTIVATOR, ESPEEspe GmbH (Us)1977-06-02

Legacy Summary#

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FDA Review#

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