Cleared Traditional

TopCEM-Try in Veneer Try-in Gel

K242572 · Rizhao Huge Biomaterials Company, Ltd. · Dental
Dec 2024
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K242572 is an FDA 510(k) clearance for the TopCEM-Try in Veneer Try-in Gel, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Rizhao Huge Biomaterials Company, Ltd. (Rizhao, CN). The FDA issued a Cleared decision on December 20, 2024, 113 days after receiving the submission on August 29, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K242572 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2024
Decision Date December 20, 2024
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690