Cleared Traditional

BC PLUS

K043562 · Vericom Co., Ltd. · Dental
Jan 2005
Decision
7d
Days
Class 2
Risk

About This 510(k) Submission

K043562 is an FDA 510(k) clearance for the BC PLUS, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Vericom Co., Ltd. (Anyang-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on January 3, 2005, 7 days after receiving the submission on December 27, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K043562 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2004
Decision Date January 03, 2005
Days to Decision 7 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