Cleared Traditional

K041324 - CALMATRIX CALCIUM SULFATE BONE GRAFT BI...

K041324 is the FDA 510(k) clearance for CALMATRIX CALCIUM SULFATE BONE GRAFT BI... by Lifecore Biomedical, Inc.. It is a Class 2 Dental device (product code LYC) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

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

K041324 is an FDA 510(k) clearance for the CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on July 19, 2004 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lifecore Biomedical, Inc. devices

Submission Details

510(k) Number K041324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 127d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LYC Bone Grafting Material, Synthetic
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LYC Bone Grafting Material, Synthetic

All 44
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K041324.
SYNTHES (USA) CHRONOS-BETA-TCP
K053022 · Synthes (Usa) · Jan 2006
CALC-I-OSS
K042583 · Ultradent Products, Inc. · Jul 2005
OSTIM
K030052 · Heraeus Kulzer, Inc. · Dec 2004
COLLAGEN DENTAL WOUND DRESSINGS
K033729 · Collagen Matrix, Inc. · Mar 2004
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
K013346 · W.L. Gore & Associates, Inc. · Dec 2001
3I CALCIUM SULFATE BONE CEMENT
K012047 · Implant Innovations, Inc. · Sep 2001