Cleared Traditional

K091512 - BUILD-IT LIGHT CURE

K091512 is an FDA 510(k) clearance for BUILD-IT LIGHT CURE, 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 162-day FDA review.

K091512 · Pentron Clinical Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
162d
Days
Class 2
Risk

K091512 is an FDA 510(k) clearance for the BUILD-IT LIGHT CURE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pentron Clinical Technologies (Orange, US). The FDA issued a Cleared decision on October 30, 2009 after a review of 162 days - an extended review 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: 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 Pentron Clinical Technologies devices

FDA 510(k) Submission Details - K091512

510(k) Number K091512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2009
Decision Date October 30, 2009
Days to Decision 162 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
35d slower than avg
Panel avg: 127d · This submission: 162d
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 K091512.
CORE-FLO D/C
K093470 · Bisco, Inc. · Feb 2010
PREMISE FLOWABLE MODIFIED
K093484 · Kerr Corporation · Jan 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
CORE*IT DUAL
K092572 · Spident Co., Ltd. · Aug 2009