Cleared Traditional

K910432 - HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER

K910432 is an FDA 510(k) clearance for HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER, manufactured by Lifecore Biomedical, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K910432 · Lifecore Biomedical, Inc. · Dental device
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May 1991
Decision
90d
Days
Class 2
Risk

K910432 is an FDA 510(k) clearance for the HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Lifecore Biomedical, Inc. (Washington, US). The FDA issued a Cleared decision on May 1, 1991 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 Lifecore Biomedical, Inc. devices

FDA 510(k) Submission Details - K910432

510(k) Number K910432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1991
Decision Date May 01, 1991
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 155
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K910432.
4060 POROUS HA PARTICULES BII PORE
K924286 · Bio-Interfaces, Inc. · Apr 1993
B1018 POROUS HA BII-PORE
K924288 · Bio-Interfaces, Inc. · Apr 1993
1840 HA PARTICLES
K921776 · Bio-Interfaces, Inc. · Dec 1992
4060 HA PARTICLES
K885067 · Bio-Interfaces, Inc. · Jan 1989
HYDROXYLAPATITE BONE GRAFT MATERIAL
K863237 · Richards Medical Co., Inc. · Dec 1986
INTERPORE 200 POROUS HYDROXYAPATITE
K860983 · Interpore Intl. · May 1986