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510(k) K922633

Device
CAVI-ZYME
Applicant
E&D DENTAL PRODUCTS, INC.
510(k) number
K922633
Product code
EJB  
Decision
Substantially Equivalent (SESE)
Decision date
1992-08-06
Date received
1992-05-20
Regulation
872.4565
Classification name
Handle, Instrument, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ED SPEHAR
Address
560 Springfield Ave. Suite 1b Westfield NJ US 07090 07090

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
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#

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FDA Review#

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