Cleared Traditional

K190930 - SmarTemp X1

K190930 is the FDA 510(k) clearance for SmarTemp X1 by Parkell, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K190930 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
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Sep 2019
Decision
148d
Days
Class 2
Risk

K190930 is an FDA 510(k) clearance for the SmarTemp X1. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on September 5, 2019 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 K190930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 127d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 91
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K190930.
Portux CAD/CAM Disc
K192153 · New Stetic, SA · Nov 2019
Ceramill A-Temp
K191843 · Amann Girrbach AG · Oct 2019
TurboTemp EZ
K191619 · Zest Anchors, LLC · Sep 2019
MD-Temp Plus
K190724 · Meta Biomed Co., Ltd. · Jul 2019
LuxaCrown, Shade A1, A2, A3, A3.5
K183337 · Dmg Chemisch Pharmazeutische Fabrik GmbH · May 2019
EVOLUX CAD/CAM PMMA BLOCKS
K182065 · Blue Dent Dental · Dec 2018