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Mezzo Omni Oral Appliance

FDA UDI

Class II (US FDA UDI)

by Asd Sleep, Llc

Identity

Trade Name
Mezzo Omni Oral Appliance FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Device Name
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. FDA UDI
Model / Reference
2 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
MO2 FDA UDI
Primary DI / UDI-DI
D156MO2 FDA UDI
510(k) Number
K130504 FDA UDI
FDA Product Code
LRK FDA UDI
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Height — 1 Inch FDA UDI
Width — 4 Inch FDA UDI
Depth — 4 Inch FDA UDI

Category: Mandible-repositioning sleep-disordered breathing orthosis

Mezzo Omni Oral Appliance by Asd Sleep, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mandible-repositioning sleep-disordered breathing orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Asd Sleep, Llc

Sources (1)

  • FDA UDI e4e4223d-0683-4c12-a08b-232eba5e512b 38 fields · synced Jun 6, 2026