Cleared Traditional

K161891 - HC Primer

K161891 is the FDA 510(k) clearance for HC Primer by Shofu Dental Corporation. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K161891 · Shofu Dental Corporation · Dental device
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Nov 2016
Decision
133d
Days
Class 2
Risk

K161891 is an FDA 510(k) clearance for the HC Primer. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on November 21, 2016 after a review of 133 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 Shofu Dental Corporation devices

Submission Details

510(k) Number K161891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2016
Decision Date November 21, 2016
Days to Decision 133 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 127d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K161891.
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
K172977 · Nanova Biomaterials, Inc. · Jan 2018
Parkell Universal Adhesive
K172176 · Parkell, Inc. · Nov 2017
SHOFU MZ Primer Plus
K172106 · Shofu Dental Corporation · Aug 2017
All-Bond Universal w/BAC (not finalized)
K161051 · Bisco, Inc. · Sep 2016
Prime&Bond Elect Universal Dental Adhesive
K151619 · Dentsply International, Inc. · Oct 2015
BRUSH&BOND PLUS
K151518 · Parkell, Inc. · Sep 2015