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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 K222211
Device Name Implant Direct Dental Implant Systems Portfolio - MR Conditional
Applicant
Implant Direct Sybron Manufacturing LLC
3050 East Hillcrest Drive
Thousand Oaks,  CA  91362
Applicant Contact Reina Choi
Correspondent
Implant Direct Sybron Manufacturing LLC
3050 East Hillcrest Drive
Thousand Oaks,  CA  91362
Correspondent Contact Reina Choi
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/25/2022
Decision Date 02/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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