Cleared Abbreviated

Apoller Flow Light Cure Flowable Composite (K180463) - 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Greenway Yw, LLC devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 127d · 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 Consultant

Iris Global, LLC
Maritza Moncayo

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 929
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K180463.
DIAFIL
K261093 · DiaDent Group International · Jun 2026
DIAFIL Bulk FLOW (Economic Package)
K261071 · DiaDent Group International · May 2026
Dual Core
K260805 · Vericom Co., Ltd. · May 2026
Dura-Crown
K261356 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Apr 2026
Grandio disc multicolor
K261357 · Voco GmbH · Apr 2026
Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)
K260152 · Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. · Apr 2026