Cleared Traditional

K003457 - UNIGRAFT

K003457 is an FDA 510(k) clearance for UNIGRAFT, manufactured by Unicare Biomedical. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K003457 · Unicare Biomedical · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
63d
Days
Class 2
Risk

K003457 is an FDA 510(k) clearance for the UNIGRAFT. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Unicare Biomedical (Laguna Hills, US). The FDA issued a Cleared decision on January 9, 2001 after a review of 63 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.

FDA 510(k) Submission Details - K003457

510(k) Number K003457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2000
Decision Date January 09, 2001
Days to Decision 63 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: 128d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYC Device Classification - Class 2, Special Controls

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 214
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K003457.
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K010320 · Depuyacromed · Mar 2001
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
K003493 · Biomet, Inc. · Feb 2001
SYMPHONY GRAFT DELIVERY SYSTEM
K003286 · Depuyacromed · Jan 2001
ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE
K994137 · Atrix Laboratories, Inc. · Sep 2000
BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION
K001598 · Col-Bar , Ltd. · Aug 2000
BIO-BLOCKS
K970569 · Geistlich-Pharma · Aug 2000
K003457 · UNIGRAFT
Download PDF FDA Summary Unicare Biomedical