Cleared Traditional

K950165 - INTERPORE IP 200 GRANULAR CORALLINE HYD...

K950165 is an FDA 510(k) clearance for INTERPORE IP 200 GRANULAR CORALLINE HYD..., manufactured by Interpore Intl.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K950165 · Interpore Intl. · Dental device
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Mar 1995
Decision
70d
Days
Class 2
Risk

K950165 is an FDA 510(k) clearance for the INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO .... Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Interpore Intl. (Irvine, US). The FDA issued a Cleared decision on March 28, 1995 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Interpore Intl. devices

FDA 510(k) Submission Details - K950165

510(k) Number K950165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date March 28, 1995
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
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 65
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K950165.
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
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