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The Luco Hybrid OSA Appliance

FDA UDI

Class II (US FDA UDI)

by Johns Dental Laboratory

Identity

Trade Name
The Luco Hybrid OSA Appliance FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Device Name
An intraoral device designed to treat primary snoring and mild to moderate obstructive sleep apnea, as well as sleep bruxism and aid in the treatment of associated tension/migraine type headaches in adults. This device is reusable. FDA UDI
Model / Reference
3014680794 FDA UDI
Description
An intraoral device designed to treat primary snoring and mild to moderate obstructive sleep apnea, as well as sleep bruxism and aid in the treatment of associated tension/migraine type headaches in adults. This device is reusable. FDA UDI

Identifiers

Primary DI / UDI-DI
00810002220241 FDA UDI
FDA Product Code
LRK FDA UDI
OCO FDA UDI
MQC 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
Not 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

The Luco Hybrid OSA Appliance by Johns Dental Laboratory — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Johns Dental Laboratory

Sources (1)

  • FDA UDI da13e98e-a445-46e6-86dd-17b193263aae 34 fields · synced May 30, 2026