Cleared Traditional

K885067 - 4060 HA PARTICLES

K885067 is an FDA 510(k) clearance for 4060 HA PARTICLES, 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 36-day FDA review.

K885067 · Bio-Interfaces, Inc. · Dental device
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Jan 1989
Decision
36d
Days
Class 2
Risk

K885067 is an FDA 510(k) clearance for the 4060 HA PARTICLES. 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 January 11, 1989 after a review of 36 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 Bio-Interfaces, Inc. devices

FDA 510(k) Submission Details - K885067

510(k) Number K885067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1988
Decision Date January 11, 1989
Days to Decision 36 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
91d faster than avg
Panel avg: 127d · This submission: 36d
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 K885067.
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
HYDROXYLAPATITE BONE GRAFT MATERIAL
K863237 · Richards Medical Co., Inc. · Dec 1986
INTERPORE 200 POROUS HYDROXYAPATITE
K860983 · Interpore Intl. · May 1986
OSTEOGRAF 2040 OSTEOGRAF 4060
K852199 · Osteotech, Inc. · Oct 1985