ORY · Tongue Suspension System
Dental · 21 CFR 872.5570 · Class 2
Overview
| Product Code | ORY |
|---|---|
| Device Name | Tongue Suspension System |
| Regulation | 21 CFR 872.5570 |
| Device Class | Class 2 |
| Review Panel | Dental |
| Implant | Yes |
Identification
Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.
Classification Rationale
Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
Special Controls
*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213159 | Encore System | Siesta Medical, Inc. | Dec 22, 2021 | SESE |
| K201238 | Encore System | Siesta Medical, Inc. | Oct 2, 2020 | SESE |
| K183310 | Encore System | Siesta Medical, Inc. | May 9, 2019 | SESE |
| K133680 | ENCORE SYSTEM | Siesta Medical, Inc. | Mar 26, 2014 | SESE |
| K121440 | ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT | Siesta Medical, Inc. | Dec 6, 2012 | SESE |
| K121814 | ENCORE TONGUE SUSPENSION SYSTEM | Siesta Medical, Inc. | Nov 7, 2012 | SESE |
| K111179 | ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN | Siesta Medical, Inc. | Jul 1, 2011 | SESE |
| K110127 | PRELUDE III TONGUE SUSPENSION SYSTEM | Siesta Medical, Inc. | Apr 8, 2011 | SESE |
| K103179 | PRELUDE II TOUNGE SUSPENSION SYSTEM | Siesta Medical, Inc. | Dec 20, 2010 | SESE |
| K101060 | SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM | Siesta Medical, Inc. | Jul 8, 2010 | SESE |
Top Applicants
- Siesta Medical, Inc. — 10 clearances
