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510(k) K854765

Device
Insta-tooth Splint Bar With & Without Teeth
Applicant
C&C SYSTEMS, INC.
510(k) number
K854765
Product code
EHP
Decision
Substantially Equivalent (SESE)
Decision date
1986-06-13
Date received
1985-11-27
Regulation
872.3285
Classification name
Clasp, Preformed
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KELLER AND
Address
Heckman, Edward Korwek 1150 17th St. NW Suite 1000 Washington DC US 20036 20036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EHP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022032ACETALInovativ, LLC2002-08-29
K983558ACETAL DENTAL/PREFORMED CLASPDentamax, Inc.1999-01-07
K974622DENTAL DMicro Dental Laboratories1998-02-10
K954971ACETAL DENTAL/PREFORMED CLASPB & H Technical Services , Ltd.1995-12-11
K955946ACETAL DENTAL/PREFORMED CLASPPressing DI Monticelli Rag. Stefano1995-12-11
K800574VACUDENT LUMIX 65Vacudent Sales Corp.1980-05-20
K800575VACUDENT LUMIX 70Vacudent Sales Corp.1980-05-20