Cleared Traditional

USTOMED Bone Fixation/Bone Augmentation Systems - PIN

K243190 · Ustomed Instrumente Ulrich Storz GmbH & Co. KG · Dental

Jun 2025

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K243190 is an FDA 510(k) clearance for the USTOMED Bone Fixation/Bone Augmentation Systems - PIN, a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by Ustomed Instrumente Ulrich Storz GmbH & Co. KG (Tuttlingen, DE). The FDA issued a Cleared decision on June 27, 2025, 270 days after receiving the submission on September 30, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.

Submission Details

510(k) Number	K243190 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	June 27, 2025
Days to Decision	270 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF