Cleared Traditional

DB-Composite

K210193 · Dimensional Bioceramics, LLC · Orthopedic
Mar 2021
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K210193 is an FDA 510(k) clearance for the DB-Composite, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Dimensional Bioceramics, LLC (Santa Cruz, US). The FDA issued a Cleared decision on March 15, 2021, 49 days after receiving the submission on January 25, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K210193 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2021
Decision Date March 15, 2021
Days to Decision 49 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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