FDA 510(k)

DB-CMF

K-Number: K182742 · 2019-06-20

Decision Date2019-06-20

Product CodeGXP

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DB-CMF is the device name listed in this FDA 510(k) record. The listed applicant is Dimensional Bioceramics, LLC. It received FDA 510(k) clearance on 2019-06-20 under 510(k) number K182742. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DB-CMF?

DB-CMF is a medical device that received FDA 510(k) clearance on 2019-06-20. The listed applicant is Dimensional Bioceramics, LLC. The 510(k) number is K182742.

When did DB-CMF receive FDA 510(k) clearance?

DB-CMF received FDA 510(k) clearance on 2019-06-20, under 510(k) number K182742.

Who is the listed applicant for DB-CMF?

The FDA 510(k) record lists Dimensional Bioceramics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DB-CMF?

The FDA product code for DB-CMF is GXP.

Other records listing Dimensional Bioceramics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212353DB-EZ Bone Void Filler K210193DB-Composite K200752DB-Orthopedics K171161Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.