Cleared Traditional

K140512 - UFILL BULK FILL POSTERIOR FLOWABLE COMP...

K140512 is an FDA 510(k) clearance for UFILL BULK FILL POSTERIOR FLOWABLE COMP..., manufactured by Juno Dentistry LP. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K140512 · Juno Dentistry LP · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
124d
Days
Class 2
Risk

K140512 is an FDA 510(k) clearance for the UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Juno Dentistry LP (Orange, US). The FDA issued a Cleared decision on July 2, 2014 after a review of 124 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 Juno Dentistry LP devices

FDA 510(k) Submission Details - K140512

510(k) Number K140512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2014
Decision Date July 02, 2014
Days to Decision 124 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
3d faster than avg
Panel avg: 127d · This submission: 124d
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 690
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K140512.
Admira Fusion
K150784 · Voco GmbH · Jul 2015
TETRIC EVOFLOW BULK FILL
K150393 · Ivoclar Vivadent, AG · Jun 2015
Variolink Esthetic
K142389 · Ivoclar Vivadent, AG · Nov 2014
ABSOLUTE DENTIN 2
K132115 · Parkell, Inc. · Jun 2014
CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)
K133850 · Prismatik Dentalcraft, Inc. · Jun 2014
HTFX-222
K133182 · GC America, Inc. · Apr 2014