Cleared Traditional

K183310 - Encore System

K183310 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 Traditional 510(k) pathway after a 161-day FDA review.

K183310 · Siesta Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
161d
Days
Class 2
Risk

K183310 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 May 9, 2019 after a review of 161 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Siesta Medical, Inc. devices

FDA 510(k) Submission Details - K183310

510(k) Number K183310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2018
Decision Date May 09, 2019
Days to Decision 161 days
Submission Type Traditional
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
34d slower than avg
Panel avg: 127d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.