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510(k) K834363

Device
ENDIX RADICULAR BIOCERAMIC PIN
Applicant
C.B.S. BIOTECHNICS, INC.
510(k) number
K834363
Product code
ELS  
Decision
Substantially Equivalent (SESE)
Decision date
1984-02-27
Date received
1983-10-27
Regulation
872.3890
Classification name
Splint, Endodontic Stabilizing
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ELS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972985SPLINT ITJeneric/Pentron, Inc.1997-09-24
K961704MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEMDentatus USA , Ltd.1996-07-26
K922673FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDINGGlasspan, Inc.1994-02-25
K811209JACOB WIRZ TRANSFIXATION PINColmed, Ltd.1981-06-16
K801525ZEST ENDODONTIC STABILIZERZest Anchors, Inc.1980-07-21

Legacy Summary#

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FDA Review#

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