Cleared Traditional

K172106 - SHOFU MZ Primer Plus

K172106 is an FDA 510(k) clearance for SHOFU MZ Primer Plus, 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 50-day FDA review.

K172106 · Shofu Dental Corporation · Dental device
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Aug 2017
Decision
50d
Days
Class 2
Risk

K172106 is an FDA 510(k) clearance for the SHOFU MZ Primer Plus. 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 August 31, 2017 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shofu Dental Corporation devices

FDA 510(k) Submission Details - K172106

510(k) Number K172106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2017
Decision Date August 31, 2017
Days to Decision 50 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
77d faster than avg
Panel avg: 127d · This submission: 50d
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 335
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K172106.
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
K172977 · Nanova Biomaterials, Inc. · Jan 2018
TOKUYAMA UNIVERSAL BOND
K171226 · Tokuyama Dental Corporation · Nov 2017
Parkell Universal Adhesive
K172176 · Parkell, Inc. · Nov 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
All-Bond Universal w/BAC (not finalized)
K161051 · Bisco, Inc. · Sep 2016