Cleared Traditional

K112428 - NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT

K112428 is an FDA 510(k) clearance for NOVABONE DENTAL MORSELS - BIOACTIVE SYN..., manufactured by Novabone Products, LLC. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K112428 · Novabone Products, LLC · Dental device
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Dec 2011
Decision
115d
Days
Class 2
Risk

K112428 is an FDA 510(k) clearance for the NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Novabone Products, LLC (Alachua, US). The FDA issued a Cleared decision on December 16, 2011 after a review of 115 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Novabone Products, LLC devices

FDA 510(k) Submission Details - K112428

510(k) Number K112428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2011
Decision Date December 16, 2011
Days to Decision 115 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
12d faster than avg
Panel avg: 127d · This submission: 115d
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 163
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K112428.
SOCKET GRAFT
K113049 · Steiner Laboratories · Jan 2012
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BLUE SKY BIO TCP
K110198 · Blue Sky Bio, LLC · Dec 2011
FOUNDATION
K111087 · Olympus Terumo Biomaterials Corporation · Nov 2011
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K103820 · Ceramisys, Ltd. · Nov 2011
ENDOBON XENOGRAFT GRANULES
K110449 · Biomet 3i · May 2011