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510(k) K935141

Device
DENTAURUM PLIERS
Applicant
DENTAURAUM, INC.
510(k) number
K935141
Product code
JEX  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-31
Date received
1993-10-28
Regulation
872.4565
Classification name
Plier, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JHN J ROTH, JR
Address
10 Pheasant Run Newtown PA US 18940 18940

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JEX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K955242TITANIUM BIRD BEAK PLIERSybron Dental Specialties, Inc.1995-12-01
K924645TRANSCEND SERIES 6000 DEBONDING INSTRUMENTSUnitek Corp.1992-11-25
K924295DEBRACKETING INSTRUMENTUnitek Corp.1992-11-23
K854088UNITEK LIFT-OFF DEBRACKETING INSTRUMENTUnitex Corp.1985-11-26
K843742UNITEK CONVERTIBLE CAP REMOVER TOOLUnitek Corp.1984-11-09
K760984ORTHODONTIC INSTRUMENTSAdp Intl., Inc.1976-11-15

Legacy Summary#

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FDA Review#

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