Cleared Traditional

K140714 - PORCINE ANORGANIC BONE MINERAL

K140714 is an FDA 510(k) clearance for PORCINE ANORGANIC BONE MINERAL, manufactured by Collagen Matrix, Inc.. The device is a Class 2 Dental device with product code NPM cleared through the Traditional 510(k) pathway after a 117-day FDA review.

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

FDA 510(k) Submission Details - K140714

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
Combination Product No
PCCP Authorized No
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.

NPM Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K140714.
InterOss
K151209 · Sigmagraft, Inc. · Nov 2015
OCS-B COLLAGEN
K142040 · Nibec Co., Ltd. · Jul 2015
TI-OSS
K140021 · Chiyewon · Jun 2015
SYNERGY
K123876 · Odontit S.A. · May 2014
GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC
K122894 · Geistlich Pharma AG · Feb 2013
OCS-B
K113246 · Nibec Company, Limited · Jan 2013