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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 K170100
Device Name CreoDent Solidex Customized Abutment and Screw
Applicant
CreoDent Prosthetics, Ltd.
29 West 30th Street
11th Floor
New York,  NY  10001
Applicant Contact Calvin Shim
Correspondent
CreoDent Prosthetics, Ltd.
29 West 30th Street
11th Floor
New York,  NY  10001
Correspondent Contact Calvin Shim
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/11/2017
Decision Date 07/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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