Cleared Abbreviated

K120372 - DR GREENBURGS HYBRID VACUUM

K120372 is an FDA 510(k) clearance for DR GREENBURGS HYBRID VACUUM, manufactured by Always More Marketing, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 142-day FDA review.

K120372 · Always More Marketing, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
142d
Days
Class 2
Risk

K120372 is an FDA 510(k) clearance for the DR GREENBURGS HYBRID VACUUM. 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.

FDA 510(k) Submission Details - K120372

510(k) Number K120372 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 128d · This submission: 142d
Pathway characteristics
Standards-based clearance path.

LRK Device Classification - Class 2, Special Controls

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 214
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K120372.
NU SLEEP
K121344 · Rh Associates, LLC · Oct 2012
SOMNOGUARD SP SOFT
K121761 · Tomed Dr. Toussaint GmbH · Sep 2012
DR GREENBURGS HYBRID ACRYLIC
K120371 · Always More Marketing, Inc. · Jun 2012
PURESLEEP
K113022 · Sleep Science Partners, Inc. · Jun 2012
SOMNODENT G2
K121340 · Somnomed, Inc. · May 2012
REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP
K103704 · Zephyr Sleep Technologies, Inc. · Mar 2012
K120372 · DR GREENBURGS HYBRID VACUUM
Download PDF FDA Summary Always More Marketing…