Cleared Traditional

K113126 - ACRYLIC HERBST APPLIANCE (FDA 510(k) Clearance)

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

K113126 · Gergens Orthodontic Lab · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
632d
Days
Class 2
Risk

K113126 is an FDA 510(k) clearance for the ACRYLIC HERBST APPLIANCE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Gergens Orthodontic Lab (Dunlap, US). The FDA issued a Cleared decision on July 17, 2013 after a review of 632 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Gergens Orthodontic Lab devices

Submission Details

510(k) Number K113126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2011
Decision Date July 17, 2013
Days to Decision 632 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
505d slower than avg
Panel avg: 127d · This submission: 632d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
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 - LRK Device, Anti-snoring

All 209
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K113126.
ShaeferH
K252942 · Shaeferh, LLC · Apr 2026
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
K253845 · Ram.Shaw Pte. , Ltd. · Mar 2026
Myosa (S1H, S1, S2, S3, S1M, S2M)
K252531 · Myofunctional Research Co. · Mar 2026
Park Dental Nylon MAD
K252976 · Park Dental Research Corp. · Dec 2025
QuietLab Pro
K253868 · QuietLab, LLC · Dec 2025
Hushd Avera
K252161 · Good Sleep CO Pte , Ltd. · Nov 2025