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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K210499
Device Name Alpha Dent Implants Dental Implants System
Applicant
Alpha Dent Implants GmbH
Hanauer St. 8
Pforzheim,  DE 75181
Applicant Contact Simha Sibony
Correspondent
Alpha Dent Implants GmbH
Hanauer St. 8
Pforzheim,  DE 75181
Correspondent Contact Simha Sibony
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received02/22/2021
Decision Date 11/01/2021
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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