Cleared Traditional

K072545 - ARTISTE SE FLOWABLE COMPOSITE, MODEL N280

K072545 is an FDA 510(k) clearance for ARTISTE SE FLOWABLE COMPOSITE, manufactured by Pentron Clinical Technologies. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K072545 · Pentron Clinical Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
46d
Days
Class 2
Risk

K072545 is an FDA 510(k) clearance for the ARTISTE SE FLOWABLE COMPOSITE, MODEL N280. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pentron Clinical Technologies (Wallingford, US). The FDA issued a Cleared decision on October 26, 2007 after a review of 46 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 Pentron Clinical Technologies devices

FDA 510(k) Submission Details - K072545

510(k) Number K072545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2007
Decision Date October 26, 2007
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 127d · This submission: 46d
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 724
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K072545.
3M ESPE ADULT CROWN
K072733 · 3M Company · Feb 2008
DENFIL ETCHANT-37
K080265 · Vericom Co., Ltd. · Feb 2008
E-1 ESTHETIC COMPOSITE SYSTEM
K072746 · Tokuyama Dental Corporation · Dec 2007
SPACER
K072069 · Vericom Co., Ltd. · Sep 2007
BEAUTIFIL II
K071742 · Shofu Dental Corp. · Aug 2007
MODIFICATION TO KAVO QUATTROCARE
K071288 · Sybron Dental Specialties, Inc. · Jul 2007