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510(k) K910090

Device
DIMAC WIRES
Applicant
INSTRUMENTATIONS UNLTD.
510(k) number
K910090
Product code
DYX  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-25
Date received
1991-01-09
Regulation
872.4600
Classification name
Lock, Wire, And Ligature, Intraoral
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CHARLES KAUFFMAN
Address
108 James St. P.O. Box 14 Quakertown PA US 18951 18951

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DYX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162046MINNE TIES MMF Suture SystemSummit Medical, Inc.2017-04-11
K061271ERCH ARCH BAR, MODEL 38-690-00KLS-Martin L.P.2006-06-30
K031207SAFETY RELEASE ARCH BAR KITCasey Surgical, LLC2003-07-15
K030605RAPID IMFZygomatics , Ltd.2003-06-27
K990212LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00Doctor'S Research Group, Inc.1999-09-14
K991004SYNTHES QUICK LOCK IMF SYSTEMSynthes (Usa)1999-06-23
K925106IMPLANTABLE PULSE GENERATORSMedtronic Vascular1993-10-06
K925712RELIANCE SHORT STICK TIEReliance Orthodontic Products, Inc.1993-01-11
K863799JAW FIXATION ASSEMBLYMedical Products & Research, Inc.1986-10-14
K820944DENTAL ARCH BARUnisplint Corp.1982-05-05

Legacy Summary#

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FDA Review#

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