Cleared Traditional

K140714 - PORCINE ANORGANIC BONE MINERAL (FDA 510(k) Clearance)

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

K140714 · Collagen Matrix, Inc. · Dental device
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Jul 2014
Decision
117d
Days
Class 2
Risk

K140714 is an FDA 510(k) clearance for the PORCINE ANORGANIC BONE MINERAL. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on July 16, 2014 after a review of 117 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 Collagen Matrix, Inc. devices

Submission Details

510(k) Number K140714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2014
Decision Date July 16, 2014
Days to Decision 117 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
10d faster than avg
Panel avg: 127d · This submission: 117d
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 K140714.
Geistlich Bio-Oss®
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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