Cleared Traditional

K161353 - ESTELITE BULK FILL Flow

K161353 is an FDA 510(k) clearance for ESTELITE BULK FILL Flow, manufactured by Tokuyama Dental Corporation. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K161353 · Tokuyama Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
322d
Days
Class 2
Risk

K161353 is an FDA 510(k) clearance for the ESTELITE BULK FILL Flow. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Tokuyama Dental Corporation (Tokyo, JP). The FDA issued a Cleared decision on April 3, 2017 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Tokuyama Dental Corporation devices

FDA 510(k) Submission Details - K161353

510(k) Number K161353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2016
Decision Date April 03, 2017
Days to Decision 322 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
195d slower than avg
Panel avg: 127d · This submission: 322d
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 649
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K161353.
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K163207 · 3M Company · Nov 2016