Cleared Traditional

OSTEOGRAF/AR AND OSTEOGRAF/AR+ (K862324) - FDA 510(k) Clearance

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

K862324 · Coors Biomedical Co. · Dental device
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Aug 1986
Decision
57d
Days
Class 2
Risk

K862324 is an FDA 510(k) clearance for the OSTEOGRAF/AR AND OSTEOGRAF/AR+. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Coors Biomedical Co. (Lakewood, US). The FDA issued a Cleared decision on August 15, 1986 after a review of 57 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 Coors Biomedical Co. devices

Submission Details

510(k) Number K862324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1986
Decision Date August 15, 1986
Days to Decision 57 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 127d · This submission: 57d
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.

Regulatory Peers - LYC Bone Grafting Material, Synthetic

All 28
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K862324.
RESOLUT REGENERATIVE MATERIAL
K970884 · W.L. Gore & Associates, Inc. · May 1997
RESOLUT REGENERATIVE MATERIAL
K962624 · W.L. Gore & Associates, Inc. · Oct 1996
RESOLUT REGENERATIVE MATERIAL
K932866 · W.L. Gore & Associates, Inc. · Mar 1995
HYDROXYAPATITE
K842718 · Depuy, Inc. · Nov 1984
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
K821752 · Depuy, Inc. · Aug 1982