CalMatrix Calcium Sulfate Bone Graft Binder

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K041324 ↗

FDA Product Code

LYC

Device Class

Class II

Regulation

21 CFR Part 872.3930

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Lifecore Biomedical, Inc. →

• What is the primary purpose of the CalMatrix Calcium Sulfate Bone Graft Binder in dental procedures?

  The CalMatrix Calcium Sulfate Bone Graft Binder is designed to stabilize and integrate bone graft materials during dental procedures. It combines surgical-grade calcium sulfate (plaster of Paris) with sodium carboxymethylcellulose (CMC) to create a composite graft that helps secure graft particles in place, promoting better integration with surrounding bone.

• How is the CalMatrix Calcium Sulfate Bone Graft Binder supplied, and does it require additional sterilization?

  The device is supplied as a dry powder that must be mixed with a provided liquid to form the composite graft. It comes in sterile, single-use packaging, so no additional sterilization is required before use. This ensures readiness for immediate application in the dental setting.

• Is the CalMatrix Calcium Sulfate Bone Graft Binder intended for single-use only, or can it be reused?

  Yes, the CalMatrix Calcium Sulfate Bone Graft Binder is explicitly packaged as a single-use product. Each sterile kit is designed for one application only, eliminating the need for reprocessing or reuse.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it fall under?

  The CalMatrix Calcium Sulfate Bone Graft Binder received FDA clearance through a Traditional 510(k) pathway under the Dental (DE) Advisory Committee. It is classified as a Class II device (device class=2) and falls under regulation number 872.3930, which pertains to bone grafting materials. The clearance was granted in 2004.

• Are there multiple package sizes available, and how does this accommodate different defect volumes?

  Yes, the CalMatrix Calcium Sulfate Bone Graft Binder is available in multiple package sizes to match varying defect volumes in dental procedures. This allows clinicians to select the appropriate quantity for their specific application, ensuring optimal coverage and integration of the graft material.