Cleared Traditional

K161684 - Quantum LB

K161684 is the FDA 510(k) clearance for Quantum LB by Reliance Orthodontic Products, Inc.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K161684 · Reliance Orthodontic Products, Inc. · Dental device
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Oct 2016
Decision
111d
Days
Class 2
Risk

K161684 is an FDA 510(k) clearance for the Quantum LB. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Reliance Orthodontic Products, Inc. (Itasca, US). The FDA issued a Cleared decision on October 6, 2016 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 Reliance Orthodontic Products, Inc. devices

Submission Details

510(k) Number K161684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2016
Decision Date October 06, 2016
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 127d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 82
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K161684.
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ORTHO-1(NOT FINALIZED)
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OPAL BOND FLOW
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