Cleared Traditional

K924286 - 4060 POROUS HA PARTICULES BII PORE

K924286 is an FDA 510(k) clearance for 4060 POROUS HA PARTICULES BII PORE, manufactured by Bio-Interfaces, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K924286 · Bio-Interfaces, Inc. · Dental device
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Apr 1993
Decision
232d
Days
Class 2
Risk

K924286 is an FDA 510(k) clearance for the 4060 POROUS HA PARTICULES BII PORE. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Bio-Interfaces, Inc. (San Diego, US). The FDA issued a Cleared decision on April 14, 1993 after a review of 232 days - an extended review 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: 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 Bio-Interfaces, Inc. devices

FDA 510(k) Submission Details - K924286

510(k) Number K924286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1992
Decision Date April 14, 1993
Days to Decision 232 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 127d · This submission: 232d
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 122
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K924286.
BII-PLAST
K934947 · Bio-Interfaces, Inc. · Jan 1994
710 POROUS HA PARTICLES-BII-PORE
K924287 · Bio-Interfaces, Inc. · Apr 1993
BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-PORE
K922487 · 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
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K910432 · Lifecore Biomedical, Inc. · May 1991