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510(k) K823489

Device
ENDODONTIC BROACH-BARBED BROACH
Applicant
UNION BROACH, DIV. MOYCO INDUSTRIES, INC.
510(k) number
K823489
Product code
EKW  
Decision
Substantially Equivalent (SESE)
Decision date
1982-12-15
Date received
1982-11-23
Regulation
872.4565
Classification name
Broach, Endodontic
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 EKW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K871493DENTI-TRAY(TM)Advanced Medical, Inc.1987-06-24
K870765CANNULATED INSTRUMENT CLEANERSTreace Medical, Inc.1987-05-27
K862523MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYSWalter Lorenz Surgical, Inc.1986-08-01
K831749ENDODONTIC BROACH(76EKN) BARBED BROACHUnion Branch1983-07-12
K800292ENDEX BROACH, ENDODONTICIpco Corp.1980-02-19
K760985HAND INSTRUMENTSAdp Intl., Inc.1976-11-15

Legacy Summary#

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FDA Review#

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