Cleared Abbreviated

Glass Ceramic

K252789 · Shenzhen Xiangtong Co., Ltd. · Dental

Dec 2025

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K252789 is an FDA 510(k) clearance for the Glass Ceramic, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Shenzhen Xiangtong Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on December 8, 2025, 97 days after receiving the submission on September 2, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K252789 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2025
Decision Date	December 08, 2025
Days to Decision	97 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF