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FDA 510(k)

DB-EZ Bone Void Filler

K-Number: K212353 · 2021-09-22

ApplicantDimensional Bioceramics, LLC
Decision Date2021-09-22
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DB-EZ Bone Void Filler 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 2021-09-22 under 510(k) number K212353. 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-EZ Bone Void Filler?

DB-EZ Bone Void Filler is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Dimensional Bioceramics, LLC. The 510(k) number is K212353.

When did DB-EZ Bone Void Filler receive FDA 510(k) clearance?

DB-EZ Bone Void Filler received FDA 510(k) clearance on 2021-09-22, under 510(k) number K212353.

Who is the listed applicant for DB-EZ Bone Void Filler?

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-EZ Bone Void Filler?

The FDA product code for DB-EZ Bone Void Filler is MQV.

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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.

K210193DB-CompositeK200752DB-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.

K260364Device 300419 StripGeistlich Pharma AGK252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd.K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft SubstituteStryker SpineK253524Adaptos®Fuse Bone GraftBiomendex OYK253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteProsidyan, Inc.K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.

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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