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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K113738
Device Name CREODENT SOLIDEX CUSTOM ABUTMENT
Applicant
CREODENT PROSTHETICS LTD.
29TH WEST STREET
11TH FLOOR
NEW YORK,  NY  10001
Applicant Contact CALVIN SHIM
Correspondent
CREODENT PROSTHETICS LTD.
29TH WEST STREET
11TH FLOOR
NEW YORK,  NY  10001
Correspondent Contact CALVIN SHIM
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/20/2011
Decision Date 09/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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