Cleared Traditional

K182296 - HyperFil-LV

K182296 is the FDA 510(k) clearance for HyperFil-LV by Parkell, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K182296 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
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Dec 2018
Decision
112d
Days
Class 2
Risk

K182296 is an FDA 510(k) clearance for the HyperFil-LV. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on December 14, 2018 after a review of 112 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 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. Standard predicate reliance. 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 Parkell, Inc. devices

Submission Details

510(k) Number K182296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2018
Decision Date December 14, 2018
Days to Decision 112 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
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 516
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K182296.
Tetric PowerFill
K183380 · Ivoclar Vivadent, AG · Mar 2019
Fit SA
K182869 · Shofu Dental Corporation · Jan 2019
3M Filtek Universal Restorative
K183476 · 3M Espe Dental Products · Jan 2019
TPH Spectra ST Flowable Composite Restorative
K182288 · Dentsply Sirona · Nov 2018
Nexcomp
K181689 · Meta Biomed Co., Ltd. · Nov 2018
Apoller Flow Light Cure Flowable Composite
K180463 · Greenway Yw, LLC · Nov 2018