Cleared Traditional

K863176 - ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+

K863176 is an FDA 510(k) clearance for ADDITIONAL CLINICAL USAGES FOR OSTEOGRA..., 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 100-day FDA review.

K863176 · Coors Biomedical Co. · Dental device
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Nov 1986
Decision
100d
Days
Class 2
Risk

K863176 is an FDA 510(k) clearance for the ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & 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 November 26, 1986 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Coors Biomedical Co. devices

FDA 510(k) Submission Details - K863176

510(k) Number K863176 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 18, 1986
Decision Date November 26, 1986
Days to Decision 100 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 128d · This submission: 100d
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 K863176.
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