Cleared Traditional

Porcine Anorganic Bone Mineral in Delivery Applicator

K162158 · Collagen Matrix, Inc. · Dental

Feb 2017

Decision

191d

Days

Class 2

Risk

About This 510(k) Submission

K162158 is an FDA 510(k) clearance for the Porcine Anorganic Bone Mineral in Delivery Applicator, 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 February 9, 2017, 191 days after receiving the submission on August 2, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K162158 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2016
Decision Date	February 09, 2017
Days to Decision	191 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.