Cleared Traditional

Geistlich Bio-Oss?

K240661 · Geistlich Pharma AG · Dental

Jul 2024

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K240661 is an FDA 510(k) clearance for the Geistlich Bio-Oss?, 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 July 12, 2024, 126 days after receiving the submission on March 8, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K240661 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2024
Decision Date	July 12, 2024
Days to Decision	126 days
Submission Type	Traditional
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.