Cleared Traditional

CAPSET CALCIUM SULFATE BONE GRAFT PLASTER

K955096 · Lifecore Biomedical, Inc. · Dental
Jan 1996
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K955096 is an FDA 510(k) clearance for the CAPSET CALCIUM SULFATE BONE GRAFT PLASTER, 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 January 23, 1996, 77 days after receiving the submission on November 7, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K955096 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1995
Decision Date January 23, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

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.