Cleared Traditional

K100235 - FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE

K100235 is an FDA 510(k) clearance for FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE, manufactured by 3M Company. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K100235 · 3M Company · Dental device
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May 2010
Decision
106d
Days
Class 2
Risk

K100235 is an FDA 510(k) clearance for the FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on May 12, 2010 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all 3M Company devices

FDA 510(k) Submission Details - K100235

510(k) Number K100235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2010
Decision Date May 12, 2010
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
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 762
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K100235.
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ESTHETICA
K100083 · Kerr Corporation · Mar 2010
CLEARFIL MAJETY POSTERIOR
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TEMP IT
K100413 · Spident Co., Ltd. · Mar 2010