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FDA 510(k)

DB-Composite

K-Number: K210193 · 2021-03-15

ApplicantDimensional Bioceramics, LLC
Decision Date2021-03-15
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DB-Composite 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 2021-03-15 under 510(k) number K210193. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DB-Composite?

DB-Composite is a medical device that received FDA 510(k) clearance on 2021-03-15. The listed applicant is Dimensional Bioceramics, LLC. The 510(k) number is K210193.

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

DB-Composite received FDA 510(k) clearance on 2021-03-15, under 510(k) number K210193.

Who is the listed applicant for DB-Composite?

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-Composite?

The FDA product code for DB-Composite is MQV.

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 FillerK200752DB-OrthopedicsK182742DB-CMFK171161Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)

Related Devices (Code: MQV)

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.

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Official Source

View on FDA Database →

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

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