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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 K192221
Device Name Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts
Applicant
Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr.
Thousand Oaks,  CA  91362
Applicant Contact Reina Choi
Correspondent
Hogan & Lovells U.S. Lpp
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/15/2019
Decision Date 06/25/2020
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
Recalls CDRH Recalls
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