Cleared Traditional

PORCINE ANORGANIC BONE MINERAL

K140714 · Collagen Matrix, Inc. · Dental

Jul 2014

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K140714 is an FDA 510(k) clearance for the PORCINE ANORGANIC BONE MINERAL, a Bone Grafting Material, Animal Source (Class II — Special Controls, product code NPM), submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on July 16, 2014, 117 days after receiving the submission on March 21, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K140714 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NPM — Bone Grafting Material, Animal Source
Device Class	Class II — 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.