510(k) K212353

DB-EZ Bone Void Filler by Dimensional Bioceramics, LLC — Product Code MQV

K212353 is an FDA 510(k) premarket notification submitted by Dimensional Bioceramics, LLC for the device "DB-EZ Bone Void Filler". The FDA issued a decision of Substantially Equivalent on September 22, 2021. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Dimensional Bioceramics, LLC has at least 4 other 510(k) clearances on record.