Cleared Traditional

K093484 - PREMISE FLOWABLE MODIFIED

K093484 is an FDA 510(k) clearance for PREMISE FLOWABLE MODIFIED, manufactured by Kerr Corporation. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K093484 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
79d
Days
Class 2
Risk

K093484 is an FDA 510(k) clearance for the PREMISE FLOWABLE MODIFIED. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on January 27, 2010 after a review of 79 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 Kerr Corporation devices

FDA 510(k) Submission Details - K093484

510(k) Number K093484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2009
Decision Date January 27, 2010
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
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 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K093484.
CLEARFIL MAJETY POSTERIOR
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TEMP IT
K100413 · Spident Co., Ltd. · Mar 2010
CORE-FLO D/C
K093470 · Bisco, Inc. · Feb 2010
COSMEDENT BRUSHABLE COMPOSITE
K092730 · Cosmedent, Inc. · Nov 2009
CLEARFIL MAJESTY POSTERIOR PLT
K092281 · Kuraray Medical, Inc. · Oct 2009
SONICFILL 2010
K091091 · Sybron Dental Specialties, Inc. · Oct 2009