Cleared Traditional

K932866 - RESOLUT REGENERATIVE MATERIAL

K932866 is the FDA 510(k) clearance for RESOLUT REGENERATIVE MATERIAL by W.L. Gore & Associates, Inc.. It is a Class 2 Dental device (product code LYC) cleared through the Traditional 510(k) pathway after a 652-day FDA review.

K932866 · W.L. Gore & Associates, Inc. · Dental device
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Mar 1995
Decision
652d
Days
Class 2
Risk

K932866 is an FDA 510(k) clearance for the RESOLUT REGENERATIVE MATERIAL. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on March 28, 1995 after a review of 652 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K932866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1993
Decision Date March 28, 1995
Days to Decision 652 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
525d slower than avg
Panel avg: 127d · This submission: 652d
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 57
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K932866.
RESOLUT REGENERATIVE MATERIAL
K962624 · W.L. Gore & Associates, Inc. · Oct 1996
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K955096 · Lifecore Biomedical, Inc. · Jan 1996
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K943186 · Lifecore Biomedical, Inc. · Apr 1995
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K910432 · Lifecore Biomedical, Inc. · May 1991
HYDROXYLAPATITE BONE GRAFT MATERIAL
K863237 · Richards Medical Co., Inc. · Dec 1986
HYDROXYAPATITE
K842718 · Depuy, Inc. · Nov 1984