Cleared Traditional

Xelis Dental 2.0

K193369 · Infinitt Healthcare Co., Ltd. · Radiology

Apr 2020

Decision

131d

Days

Class 2

Risk

About This 510(k) Submission

K193369 is an FDA 510(k) clearance for the Xelis Dental 2.0, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Infinitt Healthcare Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on April 14, 2020, 131 days after receiving the submission on December 5, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K193369 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2019
Decision Date	April 14, 2020
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF