Cleared Traditional

K110449 - ENDOBON XENOGRAFT GRANULES

K110449 is an FDA 510(k) clearance for ENDOBON XENOGRAFT GRANULES, manufactured by Biomet 3i. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K110449 · Biomet 3i · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
86d
Days
Class 2
Risk

K110449 is an FDA 510(k) clearance for the ENDOBON XENOGRAFT GRANULES. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Biomet 3i (Palm Beach Gardens, US). The FDA issued a Cleared decision on May 13, 2011 after a review of 86 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 Biomet 3i devices

FDA 510(k) Submission Details - K110449

510(k) Number K110449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2011
Decision Date May 13, 2011
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 150
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K110449.
NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT
K112428 · Novabone Products, LLC · Dec 2011
FOUNDATION
K111087 · Olympus Terumo Biomaterials Corporation · Nov 2011
REPROBONE DENTAL GRAFTING MATERIAL
K103820 · Ceramisys, Ltd. · Nov 2011
CERACELL DENTAL
K103709 · Curasan AG · Mar 2011
CARRIGEN
K100883 · Etex Corp. · Dec 2010
OSTEON, OSTEON SINUS, OSTEON LIFTING
K102015 · Genoss Co., Ltd. · Nov 2010