Cleared Traditional

COLLAGEN DENTAL MEMBRANE V

K100156 · Collagen Matrix, Inc. · Dental

Aug 2010

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K100156 is an FDA 510(k) clearance for the COLLAGEN DENTAL MEMBRANE V, a Barrier, Animal Source, Intraoral (Class II — Special Controls, product code NPL), submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on August 11, 2010, 203 days after receiving the submission on January 20, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K100156 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 20, 2010
Decision Date	August 11, 2010
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NPL — Barrier, Animal Source, Intraoral
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants.