Cleared Traditional

OCS-B (K113246) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113246 · Nibec Company, Limited · Dental device
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Jan 2013
Decision
441d
Days
Class 2
Risk

K113246 is an FDA 510(k) clearance for the OCS-B. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Nibec Company, Limited (Los Angeles, US). The FDA issued a Cleared decision on January 16, 2013 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Nibec Company, Limited devices

Submission Details

510(k) Number K113246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2011
Decision Date January 16, 2013
Days to Decision 441 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
314d slower than avg
Panel avg: 127d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NPM Bone Grafting Material, Animal Source
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Animal-source Bone Grafting Material Is A Naturally-derived Device, Such As Collagen, Intended To Fill, Augment, Or Reconstruct Periodontal Defects 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 - NPM Bone Grafting Material, Animal Source

All 38
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K113246.
Geistlich Bio-Oss®
K251786 · Geistlich Pharma AG · Jul 2025
SwissGraft X
K251613 · Geistlich Pharma AG · Jun 2025
Geistlich Bio-Flow®
K242510 · Geistlich Pharma AG · Mar 2025
Xenograft Bovine Bone Particulate
K240133 · Collagen Solutions, LLC · Aug 2024
THE Graft Collagen
K230305 · Purgo Biologics, Inc. · Jul 2024
Geistlich Bio-Oss®
K240661 · Geistlich Pharma AG · Jul 2024