Cleared Traditional

K952618 - BIO-OSS

K952618 is an FDA 510(k) clearance for BIO-OSS, manufactured by Geistlich-Pharma. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K952618 · Geistlich-Pharma · Dental device
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Aug 1995
Decision
83d
Days
Class 2
Risk

K952618 is an FDA 510(k) clearance for the BIO-OSS. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Geistlich-Pharma (Washington, US). The FDA issued a Cleared decision on August 28, 1995 after a review of 83 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 Geistlich-Pharma devices

FDA 510(k) Submission Details - K952618

510(k) Number K952618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1995
Decision Date August 28, 1995
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
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 121
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K952618.
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K955096 · Lifecore Biomedical, Inc. · Jan 1996
BIO-INTERFACES, INC,. BII-PLAST
K954763 · Bio-Interfaces, Inc. · Jan 1996
OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE
K954631 · Ceramed Corp. · Jan 1996
BIO-OSS CERAMIC
K952619 · Geistlich-Pharma · Aug 1995
BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT
K950598 · Bio-Interfaces, Inc. · Aug 1995
BIO-OSS
K952617 · Geistlich-Pharma · Aug 1995