Cleared Traditional

K042929 - ESTENIA C&B

K042929 is an FDA 510(k) clearance for ESTENIA C&B, manufactured by Kuraray Medical Kurashiki Plant. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K042929 · Kuraray Medical Kurashiki Plant · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
45d
Days
Class 2
Risk

K042929 is an FDA 510(k) clearance for the ESTENIA C&B. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kuraray Medical Kurashiki Plant (New York, US). The FDA issued a Cleared decision on December 6, 2004 after a review of 45 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 Kuraray Medical Kurashiki Plant devices

FDA 510(k) Submission Details - K042929

510(k) Number K042929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2004
Decision Date December 06, 2004
Days to Decision 45 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
82d faster than avg
Panel avg: 127d · This submission: 45d
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 753
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K042929.
TESCERA OPAQUER POWDER/SCULPTING RESIN
K042804 · Bisco, Inc. · Feb 2005
AMELOGEN PLUS
K043119 · Ultradent Products, Inc. · Dec 2004
CLEAFIL DC CORE AUTOMIX
K043177 · Kuraray Medical, Inc. · Dec 2004
GRADIA DIRECT LOFLO
K042348 · GC America, Inc. · Nov 2004
TETRIC EVOCERAM
K042819 · Ivoclar Vivadent, Inc. · Nov 2004
DENFIL
K042124 · Vericom Co., Ltd. · Aug 2004