Cleared Traditional

K100235 - FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE

K100235 is the FDA 510(k) clearance for FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE by 3M Company. It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 479
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K100235.
BEAUTIFIL FLOW PLUS
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K101213 · Voco GmbH · Aug 2010
CORE-FLO D/C
K093470 · Bisco, Inc. · Feb 2010
SONICFILL 2010
K091091 · Sybron Dental Specialties, Inc. · Oct 2009
GCUC-505
K091388 · GC America, Inc. · Jul 2009