Cleared Abbreviated

K083209 - ACRYLIC HERBST SPLINT APPLIANCE (FDA 510(k) Clearance)

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

K083209 · Specialty Appliance Works, Inc. · Dental device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 158d · This submission: 88d
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 19
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