Cleared Traditional

K170596 - TN-Brush (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170596 · Genoss Co., Ltd. · Dental device
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Sep 2017
Decision
195d
Days
Class 2
Risk

K170596 is an FDA 510(k) clearance for the TN-Brush. Classified as Scaler, Rotary (product code ELB), Class II - Special Controls.

Submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on September 11, 2017 after a review of 195 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4840 - 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 Genoss Co., Ltd. devices

Submission Details

510(k) Number K170596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2017
Decision Date September 11, 2017
Days to Decision 195 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 127d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELB Scaler, Rotary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4840
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.