Cleared Special

Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series

K253973 · Liaoning Upcera Co., Ltd. · Dental

Jan 2026

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K253973 is an FDA 510(k) clearance for the Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Liaoning Upcera Co., Ltd. (Benxi, CN). The FDA issued a Cleared decision on January 9, 2026, 29 days after receiving the submission on December 11, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K253973 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2025
Decision Date	January 09, 2026
Days to Decision	29 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF