Cleared Traditional

COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN

K110600 · Collagen Matrix, Inc. · Dental

Jul 2011

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K110600 is an FDA 510(k) clearance for the COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN, a Barrier, Animal Source, Intraoral (Class II — Special Controls, product code NPL), submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on July 29, 2011, 149 days after receiving the submission on March 2, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K110600 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 2011
Decision Date	July 29, 2011
Days to Decision	149 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.