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510(k) K833038

Device
SUMMA DISK
Applicant
SHOFU DENTAL CORP.
510(k) number
K833038
Product code
DZP  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-04
Date received
1983-09-06
Regulation
872.4535
Classification name
Instrument, Diamond, 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 DZP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K120037BLUWHITE DIAMOND DENTAL BURS MODIFIEDBeavers Dental, Div. Sybron Canada, Ltd.2012-04-20
K943841SOPHOS DENTAL DIAMONDSophos Technologic1994-09-16
K940908DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURSDunhall Pharmaceuticals, Inc.1994-08-29
K934981DENTAL DRILLEare Consulting Service1994-02-03
K923757DENTAL DIAMOND DRILLSAlpha Industrializacao DE Metais Ltda.1993-03-16
K913651MANI DIA-BURSThe Lahr Consulting Group, Inc.1992-01-14
K901967DENDIA WERK BURS AND CUTTING DISCSMicro-Aire Surgical Instruments, Inc.1990-07-13
K901262F.G. LASER (DENTAL BUR)Diamond Rotary and Carbide Intl.1990-07-09
K900089FG DIAMOND BURRSKab Gloves Unltd.1990-04-03
K8938443D DENTAL DIAMOND ROTARY INSTRUMENTSLustgarten Multi-Tech International, Inc.1989-08-11
K885233NOVA DIAMONDMicrocopy, Div. Neo-Flo, Inc.1989-02-13
K880179BEAVERS' DENTAL DIAMOND INSTRUMENTSBeavers Dental, Div. Sybron Canada, Ltd.1988-03-09
K871639DENTAL DIAMOND BURSE&D Dental Manufacturing Co.1987-05-18
K854347HYBRID POINTSShofu Dental Corp.1985-12-27
K832856GINGI CURETTAGE DIAMOND POINTSShofu Dental Corp.1983-10-04

Legacy Summary#

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FDA Review#

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