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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 K221381
Device Name KDG Abutments
Applicant
Keystone Dental, Inc.
154 Middlesex Turnpike
Burlington,  MA  01803
Applicant Contact Nancy DeAngelo
Correspondent
Aclivi, LLC
3250 Brackley Dr.
Ann Abror,  MI  48105
Correspondent Contact Chris Brown
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/13/2022
Decision Date 08/10/2022
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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