Cleared Traditional

DB-CMF

K182742 · Dimensional Bioceramics, LLC · Neurology
Jun 2019
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K182742 is an FDA 510(k) clearance for the DB-CMF, a Methyl Methacrylate For Cranioplasty (Class II — Special Controls, product code GXP), submitted by Dimensional Bioceramics, LLC (Santa Cruz, US). The FDA issued a Cleared decision on June 20, 2019, 265 days after receiving the submission on September 28, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5300.

Submission Details

510(k) Number K182742 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2018
Decision Date June 20, 2019
Days to Decision 265 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXP — Methyl Methacrylate For Cranioplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5300

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