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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K231087
Device Name Guided Surgery Kit
Applicant
Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr.
Thousand Oaks,  CA  91362
Applicant Contact Reina Choi
Correspondent
Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr.
Thousand Oaks,  CA  91362
Correspondent Contact Reina Choi
Regulation Number872.4120
Classification Product Code
DZI  
Subsequent Product Code
KCT  
Date Received04/17/2023
Decision Date 08/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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