Cleared Abbreviated

K072731 - ENDSNOR

K072731 is an FDA 510(k) clearance for ENDSNOR, manufactured by Dockstader Orthodontic Lab, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 260-day FDA review.

K072731 · Dockstader Orthodontic Lab, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
260d
Days
Class 2
Risk

K072731 is an FDA 510(k) clearance for the ENDSNOR. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Dockstader Orthodontic Lab, Inc. (Fresno, US). The FDA issued a Cleared decision on June 12, 2008 after a review of 260 days - an extended review cycle.

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 - K072731

510(k) Number K072731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2007
Decision Date June 12, 2008
Days to Decision 260 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
132d slower than avg
Panel avg: 128d · This submission: 260d
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 K072731.
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K070327 · Sybron Dental Specialties, Inc. · May 2007
SOMNOFIT
K060795 · Strategic Counsel Sarl · Dec 2006
K072731 · ENDSNOR
Download PDF FDA Summary Dockstader Orthodonti…