Cleared Abbreviated

DR GREENBURGS HYBRID ACRYLIC (K120371) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K120371 · Always More Marketing, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
142d
Days
Class 2
Risk

K120371 is an FDA 510(k) clearance for the DR GREENBURGS HYBRID ACRYLIC. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Always More Marketing, Inc. (Las Vegas, US). The FDA issued a Cleared decision on June 27, 2012 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Always More Marketing, Inc. devices

Submission Details

510(k) Number K120371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date June 27, 2012
Days to Decision 142 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 127d · This submission: 142d
Pathway characteristics
Standards-based clearance path.

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 210
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K120371.
Dormiva Anti-Snoring Mouth Guard
K261134 · Koncept Innovators, Inc. · May 2026
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