Cleared Abbreviated

K150393 - TETRIC EVOFLOW BULK FILL

K150393 is an FDA 510(k) clearance for TETRIC EVOFLOW BULK FILL, manufactured by Ivoclar Vivadent, AG. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 111-day FDA review.

K150393 · Ivoclar Vivadent, AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
111d
Days
Class 2
Risk

K150393 is an FDA 510(k) clearance for the TETRIC EVOFLOW BULK FILL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on June 9, 2015 after a review of 111 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ivoclar Vivadent, AG devices

FDA 510(k) Submission Details - K150393

510(k) Number K150393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2015
Decision Date June 09, 2015
Days to Decision 111 days
Submission Type Abbreviated
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
16d faster than avg
Panel avg: 127d · This submission: 111d
Pathway characteristics
Standards-based clearance path.

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 Consultant

Ivoclar Vivadent, Inc.
DONNA MARIE HARTNETT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 782
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