AccessGUDID - DEVICE: Mezzo Omni Oral Appliance (D156MO2)

GUDID

Device Identifier (DI) Information

Brand Name: Mezzo Omni Oral Appliance
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MO2
Company Name: ASD SLEEP, LLC

Primary DI Number: D156MO2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067409451 *Terms of Use

Device Description: American Sleep Dentistry's Mezzo Omni Oral Appliance version 2 is an oral appliance designed to treat sleep apnea. This appliances is two dental splints connected mezzolaterally by an adjustable permanent attachment. The attachmentallows the patient to adjust the mandibular articulation either forward (protension) or backward (retension). The Mezzo Omni features a lower profile designed to be worn more comfortably that prior oral attachments.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47526	Mandible-repositioning sleep-disordered breathing orthosis	A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRK	Device, Anti-Snoring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130504	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 56 and 145 Degrees Fahrenheit
Storage Environment Temperature: between 56 and 80 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Height: 1 Inch
Width: 4 Inch
Depth: 4 Inch

Device Record Status

Public Device Record Key: e4e4223d-0683-4c12-a08b-232eba5e512b
Public Version Date: June 10, 2024
Public Version Number: 1
DI Record Publish Date: May 31, 2024