Cleared Special

Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal

K192042 · Geistlich Pharma AG · Dental

Aug 2019

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K192042 is an FDA 510(k) clearance for the Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal, 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 August 29, 2019, 29 days after receiving the submission on July 31, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K192042 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2019
Decision Date	August 29, 2019
Days to Decision	29 days
Submission Type	Special
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.