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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K202675
Device Name InRoad® Dental Synthetic Bone Graft
Applicant
Osteogene Tech Corp
75 Oak St.
Norwood,  NJ  07648
Applicant Contact Daniel S. Oh
Correspondent
Jmc Medical, LLC
65 Elm St.
Chelmsford,  MA  01824
Correspondent Contact James L. O'Connor
Regulation Number872.3930
Classification Product Code
LYC  
Date Received09/15/2020
Decision Date 03/04/2022
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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