DB-Composite

FDA 510(k) K210193 · Dimensional Bioceramics, LLC

Substantially Equivalent

510(k) numberK210193

Submission

Device name
DB-Composite
Applicant
Dimensional Bioceramics, LLC
Santa Cruz, CA, US
Received
January 25, 2021
Decision date
March 15, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQV – Filler, Bone Void, Calcium Compound
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3045
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code MQV

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K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™MQV · Traditional Bone Solutions, Inc.09/11/2026SE
K260364Device 300419 StripMQV · Traditional Geistlich Pharma AG06/02/2026SE
K252797JAZBI™ Resorbable Bone Void FillerMQV · Traditional Sdip Innovations Pty, Ltd.05/26/2026SE
K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special Stryker Spine04/24/2026SE
K253524Adaptos®Fuse Bone GraftMQV · Traditional Biomendex OY02/17/2026SE
K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…MQV · Special Prosidyan, Inc.10/22/2025SE
K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™MQV · Traditional Bone Solutions, Inc.10/13/2025SE
K252085Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional Wright Medical Technology, Inc. (Stryker…09/30/2025SE
K251556Device 300423 GranulesMQV · Traditional Geistlich Pharma AG07/17/2025SE
K251720OsteoFlo HydroFiberMQV · Special SurGenTec, LLC07/02/2025SE

More from SurGenTec, LLC

510(k)DeviceDecision
K212353DB-EZ Bone Void FillerMQV · Traditional 09/22/2021SE
K200752DB-OrthopedicsMQV · Traditional 04/22/2020SE
K182742Db-CmfGXP · Traditional 06/20/2019SE
K171161Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)MQV · Traditional 09/25/2017SE

Questions and answers

When was DB-Composite cleared by the FDA?

DB-Composite (K210193) received a 510(k) decision of Substantially Equivalent on March 15, 2021, 49 days after the submission was received.

What is the product code of K210193?

The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.