Cleared Traditional

GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER

K140518 · Geistlich Pharma AG · Dental

Jul 2014

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K140518 is an FDA 510(k) clearance for the GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER, a Barrier, Animal Source, Intraoral (Class II — Special Controls, product code NPL), submitted by Geistlich Pharma AG (Washington, US). The FDA issued a Cleared decision on July 18, 2014, 140 days after receiving the submission on February 28, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K140518 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2014
Decision Date	July 18, 2014
Days to Decision	140 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.