Cleared Traditional

Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed

K171643 · Geistlich Pharma AG · Dental

Oct 2017

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K171643 is an FDA 510(k) clearance for the Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, a Barrier, Animal Source, Intraoral (Class II — Special Controls, product code NPL), submitted by Geistlich Pharma AG (Wolhusen, CH). The FDA issued a Cleared decision on October 30, 2017, 150 days after receiving the submission on June 2, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K171643 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2017
Decision Date	October 30, 2017
Days to Decision	150 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.