Cleared Traditional

T1-CS, T1-C

K183475 · Osstem Implant Co., Ltd. · Radiology
Aug 2019
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K183475 is an FDA 510(k) clearance for the T1-CS, T1-C, 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 August 30, 2019, 256 days after receiving the submission on December 17, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K183475 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2018
Decision Date August 30, 2019
Days to Decision 256 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.