Cleared Traditional

TopCEM Ceramic Primer Ceramic Coupling Agent

K242749 · Rizhao Huge Biomaterials Company, Ltd. · Dental
Nov 2024
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K242749 is an FDA 510(k) clearance for the TopCEM Ceramic Primer Ceramic Coupling Agent, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Rizhao Huge Biomaterials Company, Ltd. (Rizhao, CN). The FDA issued a Cleared decision on November 8, 2024, 57 days after receiving the submission on September 12, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K242749 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2024
Decision Date November 08, 2024
Days to Decision 57 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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