Cleared Traditional

K911524 - PALFIQUE ESTELITE

K911524 is an FDA 510(k) clearance for PALFIQUE ESTELITE, manufactured by Tokuyama America, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K911524 · Tokuyama America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
54d
Days
Class 2
Risk

K911524 is an FDA 510(k) clearance for the PALFIQUE ESTELITE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Tokuyama America, Inc. (Washington, US). The FDA issued a Cleared decision on May 29, 1991 after a review of 54 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 America, Inc. devices

FDA 510(k) Submission Details - K911524

510(k) Number K911524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1991
Decision Date May 29, 1991
Days to Decision 54 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 127d · This submission: 54d
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 670
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K911524.
CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM
K912708 · Kuraray Co. · Aug 1991
DEGULUX LIGHT CURING UNIT
K912037 · Degussa AG · Jun 1991
CHARISMA
K910263 · Kulzer, Inc. · Jun 1991
VISIO-GEM ART-SYSTEM
K905604 · Espe GmbH (Us) · Mar 1991
DURAFILL COLOR VS
K905131 · Kulzer, Inc. · Mar 1991
STOMADENT TM
K905476 · Dentsply Intl. · Feb 1991