Cleared Traditional

K862324 - OSTEOGRAF/AR AND OSTEOGRAF/AR+

K862324 is an FDA 510(k) clearance for OSTEOGRAF/AR AND OSTEOGRAF/AR+, manufactured by Coors Biomedical Co.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

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

FDA 510(k) Submission Details - K862324

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
71d faster than avg
Panel avg: 128d · This submission: 57d
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 186
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K862324.
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K910432 · Lifecore Biomedical, Inc. · May 1991
4060 HA PARTICLES
K885067 · Bio-Interfaces, Inc. · Jan 1989
HYDROXYLAPATITE BONE GRAFT MATERIAL
K863237 · Richards Medical Co., Inc. · Dec 1986
INTERPORE 200 POROUS HYDROXYAPATITE
K860983 · Interpore Intl. · May 1986
OSTEOGRAF 2040 OSTEOGRAF 4060
K852199 · Osteotech, Inc. · Oct 1985
CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG
K852682 · Calcitek, Inc. · Sep 1985