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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 K201334
Device Name Keystone Dental XL Dental Implant System
Applicant
Keystone Dental, Inc.
154 Middlesex Tpke.
Burlington,  MA  01803
Applicant Contact Linda Jalbert
Correspondent
Keystone Dental, Inc.
154 Middlesex Tpke.
Burlington,  MA  01803
Correspondent Contact Linda Jalbert
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/20/2020
Decision Date 08/18/2020
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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