Cleared Traditional

Geistlich Bio-Gide; Geistlich Bio-Gide? Shape; Geistlich Bio-Gide? Compressed; Geistlich Bio-Gide? Forte; Geistlich Bio-Gide? Perio; Geistlich Combi-Kit Collagen?; Geistlich Perio-System Combi Pack

K251062 · Geistlich Pharma AG · Dental

Aug 2025

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K251062 is an FDA 510(k) clearance for the Geistlich Bio-Gide; Geistlich Bio-Gide? Shape; Geistlich Bio-Gide? Compressed; Geistlich Bio-Gide? Forte; Geistlich Bio-Gide? Perio; Geistlich Combi-Kit Collagen?; Geistlich Perio-System Combi Pack, 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 14, 2025, 132 days after receiving the submission on April 4, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K251062 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 2025
Decision Date	August 14, 2025
Days to Decision	132 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.