Cleared Traditional

K042806 - QUADRANT UNIT-1-BOND

K042806 is an FDA 510(k) clearance for QUADRANT UNIT-1-BOND, manufactured by Cavex Holland BV. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K042806 · Cavex Holland BV · Dental device
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Nov 2004
Decision
43d
Days
Class 2
Risk

K042806 is an FDA 510(k) clearance for the QUADRANT UNIT-1-BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Cavex Holland BV (Haarlem (Holland), NL). The FDA issued a Cleared decision on November 24, 2004 after a review of 43 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 Cavex Holland BV devices

FDA 510(k) Submission Details - K042806

510(k) Number K042806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date November 24, 2004
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 127d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K042806.
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
FUTURABOND NR
K042670 · Voco GmbH · Nov 2004
M.L. PRIMER
K040079 · Shofu Dental Corp. · Sep 2004
COMPOSITE/COMPOMER REPAIR KIT
K041960 · Dmg USA, Inc. · Aug 2004