Cleared Traditional

K172176 - Parkell Universal Adhesive

K172176 is an FDA 510(k) clearance for Parkell Universal Adhesive, manufactured by Parkell, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K172176 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
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Nov 2017
Decision
125d
Days
Class 2
Risk

K172176 is an FDA 510(k) clearance for the Parkell Universal Adhesive. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on November 21, 2017 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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

FDA 510(k) Submission Details - K172176

510(k) Number K172176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2017
Decision Date November 21, 2017
Days to Decision 125 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
2d faster than avg
Panel avg: 127d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K172176.
Meta P&Bond
K180802 · Meta Biomed Co., Ltd. · Aug 2018
Acid Etchant
K172953 · American Orthodontics · Feb 2018
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
K172977 · Nanova Biomaterials, Inc. · Jan 2018
SHOFU MZ Primer Plus
K172106 · Shofu Dental Corporation · Aug 2017
HC Primer
K161891 · Shofu Dental Corporation · Nov 2016
CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
K161042 · Kuraray Noritake Dental, Inc. · Oct 2016