Cleared Traditional

K040465 - LATIT FLOW

K040465 is an FDA 510(k) clearance for LATIT FLOW, manufactured by Ab Ardent. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K040465 · Ab Ardent · Dental device
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Jul 2004
Decision
148d
Days
Class 2
Risk

K040465 is an FDA 510(k) clearance for the LATIT FLOW. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ab Ardent (Tonawanda, US). The FDA issued a Cleared decision on July 20, 2004 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ab Ardent devices

FDA 510(k) Submission Details - K040465

510(k) Number K040465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2004
Decision Date July 20, 2004
Days to Decision 148 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 127d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 690
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K040465.
GRADIA DIRECT LOFLO
K042348 · GC America, Inc. · Nov 2004
TETRIC EVOCERAM
K042819 · Ivoclar Vivadent, Inc. · Nov 2004
DENFIL
K042124 · Vericom Co., Ltd. · Aug 2004
COSMEDENT CORE PASTE
K040994 · Cosmedent, Inc. · Jun 2004
MULTICORE HB
K040795 · Ivoclar Vivadent, Inc. · May 2004
QUIXX POSTERIOR RESTORATIVE
K040144 · Dentsply International · Apr 2004