Cleared Traditional

T2

K212303 · Osstem Implant Co., Ltd. · Radiology
Sep 2021
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K212303 is an FDA 510(k) clearance for the T2, 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 21, 2021, 60 days after receiving the submission on July 23, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K212303 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2021
Decision Date September 21, 2021
Days to Decision 60 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.