Cleared Traditional

Hi-Bond Universal

K230465 · Mediclus Co., Ltd. · Dental
May 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K230465 is an FDA 510(k) clearance for the Hi-Bond Universal, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Mediclus Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on May 22, 2023, 90 days after receiving the submission on February 21, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K230465 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2023
Decision Date May 22, 2023
Days to Decision 90 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