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510(k) K111465

Device
COMPOTHIXO
Applicant
KERRHAWE SA
510(k) number
K111465
Product code
DZN  
Decision
Substantially Equivalent (SESE)
Decision date
2012-07-25
Date received
2011-05-26
Regulation
872.4565
Classification name
Instruments, Dental Hand
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Wendy Garman
Address
1717 W. Collins Ave. Orange CA US 92867 92867

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DZN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K071858DENTAL MATRIX BANDFly Cast Technologies, Inc.2007-08-31
K901919CONTACT MOLAR BANDS AND CONTOUR STRIPSIvoclar North America, Inc.1990-06-22
K861581CENTRIX PCR MOLAR MATRIX FORMS (BANDS)Centrix, Inc.1986-05-12
K844324TIGER BANDWorld Wide Outdoor Marketing1984-12-03
K840984INTERDENTAL WEDGESHealthco, Inc.1984-04-13
K822094DENTAL MATRIX BANDDentsply Intl.1982-08-16
K821444COLORED WEDGE USED TO SEPARATE TEETHMoyco Industries, Inc.1982-06-14
K801142PALODENT MATRICES & BITINE RINGSAlvin Meyer, D.D.S.1980-08-07
K801530COREFORM MOLDSSybron Corp.1980-07-28
K790555HEMO-WEDGEParker Laboratories, Inc.1980-01-17
K790599RUWA MATRIX STRIPSHowmedica Corp.1979-05-21
K790600HOWMEDICA STRIP CROWNHowmedica Corp.1979-05-21
K790633ACCOR MATRIXAccor, Inc.1979-05-17
K772314WEDGES, RETAINING, MATRIXDen-Mat Corp.1978-01-03
K772316MATRIX STRIP, DEAD-SOFTDen-Mat Corp.1978-01-03

Legacy Summary#

summary

FDA Review#

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