Cleared Traditional

K090106 - PRELUDE ONE

K090106 is an FDA 510(k) clearance for PRELUDE ONE, 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 89-day FDA review.

K090106 · Danville Materials, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
89d
Days
Class 2
Risk

K090106 is an FDA 510(k) clearance for the PRELUDE ONE. 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 March 31, 2009 after a review of 89 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 - K090106

510(k) Number K090106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 01, 2009
Decision Date March 31, 2009
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
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 K090106.
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
K091300 · CAO Group, Inc. · Jul 2009
ADHESE ONE F
K090941 · Ivoclar Vivadent, Inc. · Jul 2009
MONOBOND PLUS
K090826 · Ivoclar Vivadent, Inc. · May 2009
BEAUTIBOND
K082744 · Shofu Dental Corp. · Dec 2008
FUTURABOND M/FUTURABOND M SINGLE DOSE
K082753 · Voco GmbH · Nov 2008
G-BOND PLUS
K082768 · GC America, Inc. · Oct 2008