Cleared Traditional

Ceramic Etchant (HF-5 and HF-9)

K240153 · Liaoning Upcera Co., Ltd. · Dental
Oct 2024
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K240153 is an FDA 510(k) clearance for the Ceramic Etchant (HF-5 and HF-9), a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Liaoning Upcera Co., Ltd. (Benxi, CN). The FDA issued a Cleared decision on October 2, 2024, 257 days after receiving the submission on January 19, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K240153 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2024
Decision Date October 02, 2024
Days to Decision 257 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200