Cleared Traditional

K043562 - BC PLUS

K043562 is an FDA 510(k) clearance for BC PLUS, manufactured by Vericom Co., Ltd.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K043562 · Vericom Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
7d
Days
Class 2
Risk

K043562 is an FDA 510(k) clearance for the BC PLUS. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Vericom Co., Ltd. (Anyang-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on January 3, 2005 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vericom Co., Ltd. devices

FDA 510(k) Submission Details - K043562

510(k) Number K043562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 127d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KLE Agent, Tooth Bonding, Resin

All 318
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K043562.
BOSWORTH BOND
K043170 · Harry J. Bosworth Co. · Feb 2005
PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM
K050386 · Dentsply International · Feb 2005
HERMES BOND 2
K043043 · 3M Espe AG Dental Products · Jan 2005
CLEARFIL TRI-S BOND
K042913 · Kuraray Medical, Inc. · Nov 2004
QUADRANT UNIT-1-BOND
K042806 · Cavex Holland BV · Nov 2004
FUTURABOND NR
K042670 · Voco GmbH · Nov 2004