Cleared Special

K103179 - PRELUDE II TOUNGE SUSPENSION SYSTEM (FDA 510(k) Clearance)

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

K103179 · Siesta Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
53d
Days
Class 2
Risk

K103179 is an FDA 510(k) clearance for the PRELUDE II TOUNGE SUSPENSION SYSTEM. Classified as Tongue Suspension System (product code ORY), Class II - Special Controls.

Submitted by Siesta Medical, Inc. (Los Gatos, US). The FDA issued a Cleared decision on December 20, 2010 after a review of 53 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siesta Medical, Inc. devices

Submission Details

510(k) Number K103179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2010
Decision Date December 20, 2010
Days to Decision 53 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 127d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ORY Tongue Suspension System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
Definition Intended To Be Used For Anterior Advancement Of The Tongue Base By Means Of A Bone Screw Threaded With A Suture. It Is Indicated For The Treatment Of Obstructive Sleep Apnea (osa) And/or Snoring.
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.