Cleared Traditional

K863237 - HYDROXYLAPATITE BONE GRAFT MATERIAL

K863237 is an FDA 510(k) clearance for HYDROXYLAPATITE BONE GRAFT MATERIAL, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K863237 · Richards Medical Co., Inc. · Dental device
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Dec 1986
Decision
130d
Days
Class 2
Risk

K863237 is an FDA 510(k) clearance for the HYDROXYLAPATITE BONE GRAFT MATERIAL. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on December 29, 1986 after a review of 130 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K863237

510(k) Number K863237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1986
Decision Date December 29, 1986
Days to Decision 130 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 127d · This submission: 130d
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 72
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K863237.
RESOLUT REGENERATIVE MATERIAL
K932866 · W.L. Gore & Associates, Inc. · Mar 1995
INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS
K950165 · Interpore Intl. · Mar 1995
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K910432 · Lifecore Biomedical, Inc. · May 1991
INTERPORE 200 POROUS HYDROXYAPATITE
K860983 · Interpore Intl. · May 1986
OSTEOGRAF 2040 OSTEOGRAF 4060
K852199 · Osteotech, Inc. · Oct 1985
HYDROXYAPATITE
K842718 · Depuy, Inc. · Nov 1984