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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 K202095
Device Name CreoDent Solidex Customized Abutment and Screw
Applicant
Creodent Prosthetics, Ltd.
29 W. 30th St., 11th Floor
New York,  NY  10001
Applicant Contact Calvin Shim
Correspondent
Creodent Prosthetics, Ltd.
29 W. 30th St., 11th Floor
New York,  NY  10001
Correspondent Contact Calvin Shim
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/29/2020
Decision Date 12/16/2020
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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