Cleared Traditional

K160086 - SHOFU Enamel Conditioner

K160086 is the FDA 510(k) clearance for SHOFU Enamel Conditioner by Shofu Dental Corporation. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K160086 · Shofu Dental Corporation · Dental device
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Jul 2016
Decision
188d
Days
Class 2
Risk

K160086 is an FDA 510(k) clearance for the SHOFU Enamel Conditioner. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on July 21, 2016 after a review of 188 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K160086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2016
Decision Date July 21, 2016
Days to Decision 188 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
61d slower than avg
Panel avg: 127d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 515
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K160086.
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