Cleared Traditional

K852742 - OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40

K852742 is an FDA 510(k) clearance for OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPA..., 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 91-day FDA review.

K852742 · Coors Biomedical Co. · Dental device
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Sep 1985
Decision
91d
Days
Class 2
Risk

K852742 is an FDA 510(k) clearance for the OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40. 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 September 26, 1985 after a review of 91 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 - K852742

510(k) Number K852742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1985
Decision Date September 26, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 128d · This submission: 91d
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 K852742.
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
HYDROXYAPATITE
K842718 · Depuy, Inc. · Nov 1984
TOOTH ROOT SOCKET GAUGE
K843154 · Interpore Intl. · Oct 1984