Cleared Traditional

K210193 - DB-Composite (FDA 510(k) Clearance)

K210193 · Dimensional Bioceramics, LLC · Orthopedic device

Mar 2021

Decision

49d

Days

Class 2

Risk

K210193 is an FDA 510(k) clearance for the DB-Composite. This device is classified as 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 FDA review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K210193 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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