Cleared Traditional

Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)

K171161 · Dimensional Bioceramics, LLC · Orthopedic
Sep 2017
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K171161 is an FDA 510(k) clearance for the Dimensional Bioceramics Calcium Sulfate Device (DB-CSD), a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Dimensional Bioceramics, LLC (Scotts Valley, US). The FDA issued a Cleared decision on September 25, 2017, 158 days after receiving the submission on April 20, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K171161 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2017
Decision Date September 25, 2017
Days to Decision 158 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

Similar Devices — MQV Filler, Bone Void, Calcium Compound

All 488
Adaptos?Fuse Bone Graft
K253524 · Biomendex OY · Feb 2026
FIBERGRAFT? BG Putty GPS Bone Graft Substitute FIBERGRAFT? BG Putty Bone Graft Substitute FIBERGRAFT? AERIDYAN? Matrix Bone Graft Substitute FIBERGRAFT? BG Matrix Bone Graft Substitute
K253147 · Prosidyan, Inc. · Oct 2025
Mg OSTEOINJECT?; Mg OSTEOREVIVE?; Mg OSTEOCRETE?
K251522 · Bone Solutions, Inc. · Oct 2025
Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)
K252085 · Wright Medical Technology, Inc. (Stryker Corporation) · Sep 2025
Device 300423 Granules
K251556 · Geistlich Pharma AG · Jul 2025
OsteoFlo HydroFiber
K251720 · SurGenTec, LLC · Jul 2025