Mezzo Omni Oral Appliance MO2

GUDID D156MO2

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.

ASD SLEEP, LLC

Mandible-repositioning sleep-disordered breathing orthosis

Primary Device ID	D156MO2
NIH Device Record Key	e4e4223d-0683-4c12-a08b-232eba5e512b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Mezzo Omni Oral Appliance
Version Model Number	2
Catalog Number	MO2
Company DUNS	067409451
Company Name	ASD SLEEP, LLC
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com
Phone	8005551518
Email	support@americansleepdentistry.com

Device Dimensions

Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch
Height	1 Inch
Width	4 Inch
Depth	4 Inch

Operating and Storage Conditions

Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Temperature	Between 56 Degrees Fahrenheit and 145 Degrees Fahrenheit
Storage Environment Temperature	Between 56 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D156MO2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K130504

FDA Product Code

LRK	Device, Anti-Snoring

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-06-10
Device Publish Date	2024-05-31