Cleared Traditional

T2 Plus

K233806 · Osstem Implant Co., Ltd. · Radiology
Sep 2024
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K233806 is an FDA 510(k) clearance for the T2 Plus, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Osstem Implant Co., Ltd. (Siheung-Si, KR). The FDA issued a Cleared decision on September 6, 2024, 282 days after receiving the submission on November 29, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K233806 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2023
Decision Date September 06, 2024
Days to Decision 282 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.