Cleared Traditional

SmarTemp X1

K190930 · Parkell, Inc. · Dental
Sep 2019
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K190930 is an FDA 510(k) clearance for the SmarTemp X1, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on September 5, 2019, 148 days after receiving the submission on April 10, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K190930 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2019
Decision Date September 05, 2019
Days to Decision 148 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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