Cleared Traditional

K051808 - ESTELITE FLOW QUICK

K051808 is an FDA 510(k) clearance for ESTELITE FLOW QUICK, manufactured by Tokuyama Dental Corporation. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K051808 · Tokuyama Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
34d
Days
Class 2
Risk

K051808 is an FDA 510(k) clearance for the ESTELITE FLOW QUICK. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Tokuyama Dental Corporation (Washington, US). The FDA issued a Cleared decision on August 8, 2005 after a review of 34 days - a notably fast clearance cycle.

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: 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 Tokuyama Dental Corporation devices

FDA 510(k) Submission Details - K051808

510(k) Number K051808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2005
Decision Date August 08, 2005
Days to Decision 34 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
93d faster than avg
Panel avg: 127d · This submission: 34d
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 649
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K051808.
PREMISE FLOWABLE
K060472 · Kerr Corporation · Apr 2006
X-TRA FIL
K053391 · Voco GmbH · Feb 2006
CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE
K052097 · Dentsply International · Aug 2005
BEAUTIFIL FLOW
K051818 · Shofu Dental Corp. · Aug 2005
GRANDIO
K051867 · Voco GmbH · Jul 2005
GRANDIO FLOW
K051868 · Voco GmbH · Jul 2005