Cleared Traditional

HyperFil-LV

K182296 · Parkell, Inc. · Dental
Dec 2018
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K182296 is an FDA 510(k) clearance for the HyperFil-LV, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on December 14, 2018, 112 days after receiving the submission on August 24, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K182296 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690