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510(k) K823913

Device
SOFT GRIP UNI-HANDLE
Applicant
TREACE MEDICAL, INC.
510(k) number
K823913
Product code
EJB  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-26
Date received
1982-12-28
Regulation
872.4565
Classification name
Handle, Instrument, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EJB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140144BENDA WEDGECentrix, Inc.2014-07-08
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

Legacy Summary#

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FDA Review#

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