Cleared Traditional

K120453 - FILTEK BULK FILL FLOWABLE RESTORATIVE

K120453 is an FDA 510(k) clearance for FILTEK BULK FILL FLOWABLE RESTORATIVE, 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 34-day FDA review.

K120453 · 3M Espe Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
34d
Days
Class 2
Risk

K120453 is an FDA 510(k) clearance for the FILTEK BULK FILL FLOWABLE RESTORATIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by 3M Espe Dental Products (St. Paul, US). The FDA issued a Cleared decision on March 19, 2012 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 3M Espe Dental Products devices

FDA 510(k) Submission Details - K120453

510(k) Number K120453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2012
Decision Date March 19, 2012
Days to Decision 34 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
94d faster than avg
Panel avg: 128d · This submission: 34d
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

Intertek Testing Services
WILLIAM SAMMONS

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 K120453.
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