Dental Device Guide
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Therapeutic devices · 21 CFR 872 Subpart F

Tongue Suspension System

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.

FDA codeORYClass221 CFR872.5570Pathway510(k)Implant
Companies listing it
43 makers
Brands and models
2
510(k) clearances
101 in five years
FDA name
Tongue Suspension System
2010: 22011: 22012: 22014: 12019: 12020: 12021: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list ORY

4 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Siesta Medical, Inc.United StatesMakerEncore System102021
Wright Engineered Plastics, Inc.United StatesMakerEncore, Activities——
Autocam MedicalUnited StatesMaker———
Parter Sterilization Services / Parter Medical ProductsUnited StatesContract sterilizer———

510(k) clearances

Decided510(k)DeviceApplicant
22 Dec 2021K213159Encore SystemSiesta Medical, Inc.
2 Oct 2020K201238Encore SystemSiesta Medical, Inc.
9 May 2019K183310Encore SystemSiesta Medical, Inc.
26 Mar 2014K133680ENCORE SYSTEMSiesta Medical, Inc.
6 Dec 2012K121440ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KITSiesta Medical, Inc.
7 Nov 2012K121814ENCORE TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.
1 Jul 2011K111179ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMENSiesta Medical, Inc.
8 Apr 2011K110127PRELUDE III TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.
20 Dec 2010K103179PRELUDE II TOUNGE SUSPENSION SYSTEMSiesta Medical, Inc.
8 Jul 2010K101060SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.

Official records: FDA product classification for ORY · 21 CFR 872.5570.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026