DB-EZ Bone Void Filler

Filler, Bone Void, Calcium Compound

Dimensional Bioceramics, LLC.

The following data is part of a premarket notification filed by Dimensional Bioceramics, Llc. with the FDA for Db-ez Bone Void Filler.

Pre-market Notification Details

Device IDK212353
510k NumberK212353
Device Name:DB-EZ Bone Void Filler
ClassificationFiller, Bone Void, Calcium Compound
Applicant Dimensional Bioceramics, LLC. 2161 Delaware Avenue, Suite A Santa Cruz,  CA  95060
ContactDuran N. Yetkinliner
CorrespondentPatsy J. Trisler
Trisler Consulting 7949 Beaumont Green East Drive Indianapolis,  IN  46250
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-29
Decision Date2021-09-22

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