Cleared Traditional

Pre-Sintered Zirconia Coloring Liquid

K232682 · Chengdu Besmile Medical Technology Co., Ltd. · Dental

Mar 2024

Decision

200d

Days

Class 2

Risk

About This 510(k) Submission

K232682 is an FDA 510(k) clearance for the Pre-Sintered Zirconia Coloring Liquid, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Chengdu Besmile Medical Technology Co., Ltd. (Chengdu, CN). The FDA issued a Cleared decision on March 19, 2024, 200 days after receiving the submission on September 1, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K232682 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 01, 2023
Decision Date	March 19, 2024
Days to Decision	200 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF