Model: IBNE
DI: D775IBNE0
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3def9e09-07dd-4537-bf5f-82e08666d4d0
Distribution Status:
In Commercial Distribution
DUNS Number:
041854332
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
D775IBNE0
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 47528
Name: Palate-lifting sleep-disordered breathing orthosis
Definition:
A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by elevating the soft palate (soft tissue constituting the back of the roof of the mouth). It works by applying pressure to retract and lift a drooping soft palate, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. This is a reusable device.
FDA Product Codes
LRK
Device, Anti-Snoring
Premarket Submissions
Submission Number:
K955822
Supplement Number:
000