Product code OZR— Dental

WINX SLEEP THERAPY SYSTEM

Classification name: Intraoral Pressure Gradient Device
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Total cleared: 6
First cleared: 2012-03-30
Most recent: 2023-06-16

FDA classification definition

“This intraoral device is electrically powered and operates by reducing the pressure in the oral cavity (by way of tubing and a noninvasive oral interface) to create a continuous positive pressure gradient from the airway to the oral cavity that urges the soft palate and tongue forward. It is intended to be used while a patient is sleeping to treat obstructive sleep apnea.”
— U.S. Food and Drug Administration, device classification record for product code OZR under 21 CFR 872.5570, via openFDA

Market context for product code OZR

FDA has cleared 6 devices under product code OZR between 2012 and 2023, filed by 3 applicant companies. 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

20231 clearance
20201 clearance
20141 clearance
20131 clearance
20122 clearances

Top applicants under product code OZR

Apnicure, Inc.4 clearances
Somnics, Inc.1 clearance
Somnice, Inc.1 clearance

Recent clearances under product code OZR

K220907 — The iNAP One Sleep Therapy SystemSomnics, Inc.·2023-06-16
K193460 — The iNAP One Sleep Therapy SystemSomnice, Inc.·2020-05-26
K132003 — WINX SLEEP THERAPY SYSTEMApnicure, Inc.·2014-06-13
K130538 — WINX SLEEP THERAPY SYSTEMApnicure, Inc.·2013-05-22
K122130 — WINX SLEEP THERAPY SYSTEMApnicure, Inc.·2012-10-31
K111549 — ATTUNE SLEEP APNEA SYSTEMApnicure, Inc.·2012-03-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.