Cleared Traditional

K143209 - SonicFill 2

K143209 is an FDA 510(k) clearance for SonicFill 2, manufactured by Sybron Dental Specialties. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K143209 · Sybron Dental Specialties · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
87d
Days
Class 2
Risk

K143209 is an FDA 510(k) clearance for the SonicFill 2. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sybron Dental Specialties (Orange, US). The FDA issued a Cleared decision on February 5, 2015 after a review of 87 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 Sybron Dental Specialties devices

FDA 510(k) Submission Details - K143209

510(k) Number K143209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2014
Decision Date February 05, 2015
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 K143209.
Rhondium One-Visit-Crown(OVC)
K143694 · Rhondium, Ltd. · May 2015
Nuance FLOW
K143679 · Den-Mat Holdings, LLC · May 2015
Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
K143104 · Kettenbach GmbH & Co. KG · Mar 2015
Variolink Esthetic
K142389 · Ivoclar Vivadent, AG · Nov 2014
BULK FILL FLOWABLE COMPOSITE
K141994 · Novocol, Inc. · Nov 2014
ENADEN FLOW
K140976 · Km Corporation · Jul 2014