Cleared Traditional

K040952 - PRELUDE

K040952 is an FDA 510(k) clearance for PRELUDE, manufactured by Danville Materials, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K040952 · Danville Materials, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
78d
Days
Class 2
Risk

K040952 is an FDA 510(k) clearance for the PRELUDE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Danville Materials, Inc. (San Ramon, US). The FDA issued a Cleared decision on June 29, 2004 after a review of 78 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 Danville Materials, Inc. devices

FDA 510(k) Submission Details - K040952

510(k) Number K040952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2004
Decision Date June 29, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
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 344
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K040952.
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
G-BOND
K041471 · GC America, Inc. · Jun 2004
XENO NM LIGHT CURED DENTAL ADHESIVE
K041343 · Dentsply International · Jun 2004
MODIFICATION TO ADPER PROMPT
K040857 · 3M Espe AG Dental Products · May 2004