Cleared Traditional

K083858 - BOND BONE

K083858 is an FDA 510(k) clearance for BOND BONE, manufactured by Augma Biomaterials, Ltd.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K083858 · Augma Biomaterials, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
83d
Days
Class 2
Risk

K083858 is an FDA 510(k) clearance for the BOND BONE. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Augma Biomaterials, Ltd. (San Diego, US). The FDA issued a Cleared decision on March 17, 2009 after a review of 83 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 Augma Biomaterials, Ltd. devices

FDA 510(k) Submission Details - K083858

510(k) Number K083858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2008
Decision Date March 17, 2009
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
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 88
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K083858.
MEDTRONIC DENTAL TCP
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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
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082917 · Medtronic Sofamor Danek · Jan 2009
MASTERGRAFT PUTTY
K081784 · Medtronic Sofamor Danek · Sep 2008