Cleared Traditional

Xenograft Bovine Bone Particulate

K240133 · Collagen Solutions, LLC · Dental
Aug 2024
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K240133 is an FDA 510(k) clearance for the Xenograft Bovine Bone Particulate, a Bone Grafting Material, Animal Source (Class II — Special Controls, product code NPM), submitted by Collagen Solutions, LLC (Eden Prairie, US). The FDA issued a Cleared decision on August 16, 2024, 211 days after receiving the submission on January 18, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K240133 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2024
Decision Date August 16, 2024
Days to Decision 211 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.