Cleared Special

SwissGraft X

K251613 · Geistlich Pharma AG · Dental

Jun 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K251613 is an FDA 510(k) clearance for the SwissGraft X, a Bone Grafting Material, Animal Source (Class II — Special Controls, product code NPM), submitted by Geistlich Pharma AG (Wolhusen, CH). The FDA issued a Cleared decision on June 26, 2025, 30 days after receiving the submission on May 27, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K251613 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2025
Decision Date	June 26, 2025
Days to Decision	30 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NPM — Bone Grafting Material, Animal Source
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	A Animal-source Bone Grafting Material Is A Naturally-derived Device, Such As Collagen, Intended To Fill, Augment, Or Reconstruct Periodontal Defects And Or Bony Defects Of The Upper Or Lower Jaw.