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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 K191458
Device Name Legacy SMARTBase Abutments
Implant Direct Sybron Manufacturing LLC
3050 East Hillcrest Drive
Thousand Oaks,  CA  91362
Applicant Contact Reina Choi
Hogan Lovells U.S. LLP
3 Embarcadero Center #1500
San Francisco,  CA  94111
Correspondent Contact Yarmela Pavlovic
Regulation Number872.3630
Classification Product Code
Subsequent Product Code
Date Received05/31/2019
Decision Date 10/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No