Cleared Traditional

K161891 - HC Primer

K161891 is an FDA 510(k) clearance for HC Primer, manufactured by Shofu Dental Corporation. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K161891

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.

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 370
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K161891.
Parkell Universal Adhesive
K172176 · Parkell, Inc. · Nov 2017
SHOFU MZ Primer Plus
K172106 · Shofu Dental Corporation · Aug 2017
RnD TE and RnD SE
K161077 · Apex Dental Materials, Inc. · Mar 2017
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
All-Bond Universal w/BAC (not finalized)
K161051 · Bisco, Inc. · Sep 2016
One Coat 7 Universal
K152243 · Coltene/Whaledent AG · Dec 2015