Cleared Abbreviated

K083209 - ACRYLIC HERBST SPLINT APPLIANCE

K083209 is an FDA 510(k) clearance for ACRYLIC HERBST SPLINT APPLIANCE, manufactured by Specialty Appliance Works, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 88-day FDA review.

K083209 · Specialty Appliance Works, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
88d
Days
Class 2
Risk

K083209 is an FDA 510(k) clearance for the ACRYLIC HERBST SPLINT APPLIANCE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Specialty Appliance Works, Inc. (Cumming, US). The FDA issued a Cleared decision on January 27, 2009 after a review of 88 days - a notably fast clearance 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.

View all Specialty Appliance Works, Inc. devices

FDA 510(k) Submission Details - K083209

510(k) Number K083209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2008
Decision Date January 27, 2009
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
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 168
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K083209.
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