Cleared Traditional

XT Stain/Glaze

K223192 · Shenzhen Xiangtong Co., Ltd. · Dental

Mar 2023

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K223192 is an FDA 510(k) clearance for the XT Stain/Glaze, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Shenzhen Xiangtong Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 27, 2023, 165 days after receiving the submission on October 13, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K223192 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 13, 2022
Decision Date	March 27, 2023
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF