Cleared Special

K111179 - ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN

K111179 is an FDA 510(k) clearance for ENCORE TONGUE SUSPENSION SYSTEM (MONOFI..., manufactured by Siesta Medical, Inc.. The device is a Class 2 Dental device with product code ORY cleared through the Special 510(k) pathway after a 65-day FDA review.

K111179 · Siesta Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
65d
Days
Class 2
Risk

K111179 is an FDA 510(k) clearance for the ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE T.... 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 July 1, 2011 after a review of 65 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

FDA 510(k) Submission Details - K111179

510(k) Number K111179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2011
Decision Date July 01, 2011
Days to Decision 65 days
Submission Type Special
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
63d faster than avg
Panel avg: 128d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

ORY Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ORY Tongue Suspension System

All 9
Devices cleared under the same product code (ORY) and FDA review panel - the closest regulatory comparables to K111179.
ENCORE SYSTEM
K133680 · Siesta Medical, Inc. · Mar 2014
ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT
K121440 · Siesta Medical, Inc. · Dec 2012
ENCORE TONGUE SUSPENSION SYSTEM
K121814 · Siesta Medical, Inc. · Nov 2012
PRELUDE III TONGUE SUSPENSION SYSTEM
K110127 · Siesta Medical, Inc. · Apr 2011
PRELUDE II TOUNGE SUSPENSION SYSTEM
K103179 · Siesta Medical, Inc. · Dec 2010
SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM
K101060 · Siesta Medical, Inc. · Jul 2010