Cleared Abbreviated

K180463 - Apoller Flow Light Cure Flowable Composite (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K180463 · Greenway Yw, LLC · Dental device
Nov 2018
Decision
266d
Days
Class 2
Risk

K180463 is an FDA 510(k) clearance for the Apoller Flow Light Cure Flowable Composite. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Greenway Yw, LLC (Lake Bluff, US). The FDA issued a Cleared decision on November 14, 2018 after a review of 266 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 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.

Submission Details

510(k) Number K180463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2018
Decision Date November 14, 2018
Days to Decision 266 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 158d · This submission: 266d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 27
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K180463.
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