Cleared Traditional

K141081 - FILTEK BULK FILL POSTERIOR RESTROATIVE

K141081 is an FDA 510(k) clearance for FILTEK BULK FILL POSTERIOR RESTROATIVE, manufactured by 3M Espe Dental Products. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K141081 · 3M Espe Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
13d
Days
Class 2
Risk

K141081 is an FDA 510(k) clearance for the FILTEK BULK FILL POSTERIOR RESTROATIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by 3M Espe Dental Products (Saint Paul, US). The FDA issued a Cleared decision on May 8, 2014 after a review of 13 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 3M Espe Dental Products devices

FDA 510(k) Submission Details - K141081

510(k) Number K141081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2014
Decision Date May 08, 2014
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 127d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K141081.
Variolink Esthetic
K142389 · Ivoclar Vivadent, AG · Nov 2014
ABSOLUTE DENTIN 2
K132115 · Parkell, Inc. · Jun 2014
CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)
K133850 · Prismatik Dentalcraft, Inc. · Jun 2014
HTFX-222
K133182 · GC America, Inc. · Apr 2014
CERASMART
K133824 · GC America, Inc. · Mar 2014
BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK
K132748 · Shofu Dental Corporation · Dec 2013