Cleared Special

K201238 - Encore System

K201238 is an FDA 510(k) clearance for Encore System, 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 148-day FDA review.

K201238 · Siesta Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
148d
Days
Class 2
Risk

K201238 is an FDA 510(k) clearance for the Encore 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 October 2, 2020 after a review of 148 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K201238

510(k) Number K201238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2020
Decision Date October 02, 2020
Days to Decision 148 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
20d slower than avg
Panel avg: 128d · This submission: 148d
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 K201238.
Encore System
K213159 · Siesta Medical, Inc. · Dec 2021
Encore System
K183310 · Siesta Medical, Inc. · May 2019
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
ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
K111179 · Siesta Medical, Inc. · Jul 2011