Product code ORY— Dental
Encore System
- Classification name
- Tongue Suspension System
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Total cleared
- 10
- First cleared
- Most recent
FDA classification 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.”
Market context for product code ORY
FDA has cleared devices under product code ORY between 2010 and 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2021
- 2020
- 2019
- 2014
- 2012
- 2011
- 2010
Top applicants under product code ORY
Recent clearances under product code ORY
- K213159 — Encore System
- K201238 — Encore System
- K183310 — Encore System
- K133680 — ENCORE SYSTEM
- K121440 — ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT
- K121814 — ENCORE TONGUE SUSPENSION SYSTEM
- K111179 — ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
- K110127 — PRELUDE III TONGUE SUSPENSION SYSTEM
- K103179 — PRELUDE II TOUNGE SUSPENSION SYSTEM
- K101060 — SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.