Cleared Special

SwissMembrane X; SwissMembrane X Socket

K250833 · Geistlich Pharma AG · Dental

Apr 2025

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K250833 is an FDA 510(k) clearance for the SwissMembrane X; SwissMembrane X Socket, 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 April 15, 2025, 27 days after receiving the submission on March 19, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K250833 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 2025
Decision Date	April 15, 2025
Days to Decision	27 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.