Cleared Special

K100671 - NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHET...

K100671 is the FDA 510(k) clearance for NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHET... by Novabone Products, LLC. It is a Class 2 Dental device (product code LYC) cleared through the Special 510(k) pathway after a 21-day FDA review.

K100671 · Novabone Products, LLC · Dental device
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Mar 2010
Decision
21d
Days
Class 2
Risk

K100671 is an FDA 510(k) clearance for the NOVABONE DENTAL PUTTY-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 March 30, 2010 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Novabone Products, LLC devices

Submission Details

510(k) Number K100671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2010
Decision Date March 30, 2010
Days to Decision 21 days
Submission Type Special
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
106d faster than avg
Panel avg: 127d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 54
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K100671.
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K092087 · Medtronic Sofamor Danek USA, Inc. · Dec 2009
NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
K091484 · Novabone Products, LLC · Jun 2009
SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K083742 · Collagen Matrix, Inc. · Feb 2009