Cleared Traditional

CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER

K041324 · Lifecore Biomedical, Inc. · Dental
Jul 2004
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K041324 is an FDA 510(k) clearance for the CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on July 19, 2004, 62 days after receiving the submission on May 18, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K041324 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2004
Decision Date July 19, 2004
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LYC — Bone Grafting Material, Synthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw.