Cleared Traditional

K162046 - MINNE TIES MMF Suture System (FDA 510(k) Clearance)

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

K162046 · Summit Medical, Inc. · Dental device
Apr 2017
Decision
260d
Days
Class 2
Risk

K162046 is an FDA 510(k) clearance for the MINNE TIES MMF Suture System. Classified as Lock, Wire, And Ligature, Intraoral (product code DYX), Class II - Special Controls.

Submitted by Summit Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on April 11, 2017 after a review of 260 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4600 - 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.

Submission Details

510(k) Number K162046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2016
Decision Date April 11, 2017
Days to Decision 260 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 158d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYX Lock, Wire, And Ligature, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4600
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.