Cleared Traditional

COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP

K141909 · Collagen Matrix, Inc. · Dental

Nov 2014

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K141909 is an FDA 510(k) clearance for the COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP, 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 November 5, 2014, 113 days after receiving the submission on July 15, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K141909 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2014
Decision Date	November 05, 2014
Days to Decision	113 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.