FDA product code ORY: Tongue Suspension System
ORY is the FDA product code for tongue suspension system. It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Dental panel. FDA has cleared 10 510(k) submissions under ORY. The average 510(k) review took 114 days (median 100).
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.
Classification
| Field | Value |
|---|---|
| Device name | Tongue Suspension System |
| Device class | Class II |
| Regulation | 21 CFR 872.5570 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for ORY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 161 |
| 2020 | 1 | 148 |
| 2021 | 1 | 85 |
Compare with all 510(k) review times · Search every ORY clearance
Top ORY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siesta Medical, Inc. | 10 | 2021-12-22 |
Most recent ORY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213159 | Siesta Medical, Inc. | Encore System | 2021-12-22 | 85 |
| K201238 | Siesta Medical, Inc. | Encore System | 2020-10-02 | 148 |
| K183310 | Siesta Medical, Inc. | Encore System | 2019-05-09 | 161 |
| K133680 | Siesta Medical, Inc. | ENCORE SYSTEM | 2014-03-26 | 114 |
| K121440 | Siesta Medical, Inc. | ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT | 2012-12-06 | 205 |
Recalls for ORY devices
openFDA lists no recalls for product code ORY.
Frequently asked questions
What is FDA product code ORY?
ORY is the FDA product code for tongue suspension system. It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Dental panel.
What device class is ORY?
Class II, regulation 21 CFR 872.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code ORY?
Across 10 cleared submissions the average was 114 days from receipt to decision (median 100).
Which companies have the most ORY clearances?
Siesta Medical, Inc. (10).
Next steps
- Run an FDA pathway report with predicate devices for product code ORY
- Run a recall and safety report across every ORY manufacturer
- Watch product code ORY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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