Cleared Traditional

K060285 - BONEGEN - TR

K060285 is an FDA 510(k) clearance for BONEGEN - TR, manufactured by Bio-Lok Intl., Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K060285 · Bio-Lok Intl., Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
41d
Days
Class 2
Risk

K060285 is an FDA 510(k) clearance for the BONEGEN - TR. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Bio-Lok Intl., Inc. (Springfield, US). The FDA issued a Cleared decision on March 16, 2006 after a review of 41 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.

FDA 510(k) Submission Details - K060285

510(k) Number K060285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2006
Decision Date March 16, 2006
Days to Decision 41 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
87d faster than avg
Panel avg: 128d · This submission: 41d
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 220
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K060285.
REGEN BIOCEMENT
K063010 · Steiner Laboratories · Nov 2006
SOCKET GRAFT
K052493 · Steiner Laboratories · Jun 2006
MBCP GEL
K060732 · Biomatlante · Jun 2006
OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)
K053374 · Ossacur AG · Feb 2006
PERIOGLAS BONE GRAFT PARTICULATE
K053387 · Novabone Products, LLC · Feb 2006
SYNTHES (USA) CHRONOS-BETA-TCP
K053022 · Synthes (Usa) · Jan 2006
K060285 · BONEGEN - TR
Download PDF FDA Summary Bio-Lok Intl., Inc.