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OASYS (Oral/Nasal Airway System)

FDA UDI

Class I (US FDA UDI)

by Johns Dental Laboratory

Identity

Trade Name
OASYS (Oral/Nasal Airway System) FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Device Name
A removable intraoral device intended to reduce or alleviate snoring and obstructive sleep apnea in adults. This is a reusable device. FDA UDI
Model / Reference
3014680794 FDA UDI
Description
A removable intraoral device intended to reduce or alleviate snoring and obstructive sleep apnea in adults. This is a reusable device. FDA UDI

Identifiers

Primary DI / UDI-DI
00810002220210 FDA UDI
FDA Product Code
LWF FDA UDI
LRK FDA UDI
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.3900 FDA UDI
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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Mandible-repositioning sleep-disordered breathing orthosis

OASYS (Oral/Nasal Airway System) by Johns Dental Laboratory — Class I — 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
Johns Dental Laboratory

Sources (1)

  • FDA UDI 8a54de22-d782-4546-bbe4-9dd82df6a7a9 33 fields · synced Jun 8, 2026