Cleared Traditional

K063549 - NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K063549 · Novabone Products, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Feb 2007
Decision
80d
Days
Class 2
Risk

K063549 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 February 12, 2007 after a review of 80 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 Novabone Products, LLC devices

Submission Details

510(k) Number K063549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2006
Decision Date February 12, 2007
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 127d · This submission: 80d
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.