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510(k) K140144

Device
BENDA WEDGE
Applicant
CENTRIX, INC.
510(k) number
K140144
Product code
EJB  
Decision
Substantially Equivalent (SESE)
Decision date
2014-07-08
Date received
2014-01-22
Regulation
872.4565
Classification name
Handle, Instrument, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GREG MOREAU
Address
770 River Rd. Shelton CT US 06484 06484

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EJB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023367DETECTAR, MODEL N123-MINeks Technologies2003-06-25
K981234FLARE,FILE, FILLLone Star Technologies1998-06-05
K930094AUKUSLEEVEAukland Medical Plastics, Inc.1993-10-20
K922633CAVI-ZYMEE&D Dental Products, Inc.1992-08-06
K871818SPATULA, DENTAL, CEMENTMilitary Engineering, Inc.1987-07-02
K833338TOOTH SLOOTHJoel Lander D.D.S.1983-11-25
K823913SOFT GRIP UNI-HANDLETreace Medical, Inc.1983-01-26

Legacy Summary#

summary

FDA Review#

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