Cleared Traditional

K962624 - RESOLUT REGENERATIVE MATERIAL

K962624 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 90-day FDA review.

K962624 · W.L. Gore & Associates, Inc. · Dental device
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Oct 1996
Decision
90d
Days
Class 2
Risk

K962624 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 October 3, 1996 after a review of 90 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K962624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1996
Decision Date October 03, 1996
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K962624.
ENDOBON
K980679 · Biomet, Inc. · Apr 1998
GORE RESOLUT XT REGENERATIVE MATERIAL
K973594 · W.L. Gore & Associates, Inc. · Dec 1997
RESOLUT REGENERATIVE MATERIAL
K970884 · W.L. Gore & Associates, Inc. · May 1997
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K955096 · Lifecore Biomedical, Inc. · Jan 1996
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K943186 · Lifecore Biomedical, Inc. · Apr 1995
RESOLUT REGENERATIVE MATERIAL
K932866 · W.L. Gore & Associates, Inc. · Mar 1995