Cleared Traditional

Dental Porcelain Powder

K232676 · Chengdu Besmile Medical Technology Co., Ltd. · Dental
Jan 2024
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K232676 is an FDA 510(k) clearance for the Dental Porcelain Powder, 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 January 23, 2024, 144 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 K232676 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2023
Decision Date January 23, 2024
Days to Decision 144 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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