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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 128d · 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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 843
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K141081.
UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE
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K132115 · Parkell, Inc. · Jun 2014
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K133850 · Prismatik Dentalcraft, Inc. · Jun 2014
HTFX-222
K133182 · GC America, Inc. · Apr 2014
TRINIA
K133608 · Bicon, LLC · Mar 2014
CERASMART
K133824 · GC America, Inc. · Mar 2014