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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 K220482
Device Name Sherlock
Applicant
Open Implants, LLC
800 W. Cummings Ave., Suite 4900
Woburn,  MA  01801
Applicant Contact Gregg Gellman
Correspondent
Aclivi, LLC
3250 Brackley Dr.
Ann Abror,  MI  48105
Correspondent Contact Chris Brown
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/18/2022
Decision Date 06/21/2022
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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