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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K212353
Device Name DB-EZ Bone Void Filler
Applicant
Dimensional Bioceramics, LLC
2161 Delaware Ave., Suite A
Santa Cruz,  CA  95060
Applicant Contact Duran N. Yetkinliner
Correspondent
Trisler Consulting
7949 Beaumont Green E. Dr.
Indianapolis,  IN  46250
Correspondent Contact Patsy J. Trisler
Regulation Number888.3045
Classification Product Code
MQV  
Date Received07/29/2021
Decision Date 09/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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