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Vivos DNA

FDA UDI

Class II (US FDA UDI)

by Johns Dental Laboratory

Identity

Trade Name
Vivos DNA FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Device Name
Intraoral appliance intended to reduce snoring and/or mild to moderate obstructive sleep apnea (OSA) in adults over 18 years of age or older. FDA UDI
Model / Reference
3014680794 FDA UDI
Description
Intraoral appliance intended to reduce snoring and/or mild to moderate obstructive sleep apnea (OSA) in adults over 18 years of age or older. FDA UDI

Identifiers

Primary DI / UDI-DI
00810002220197 FDA UDI
FDA Product Code
LRK FDA UDI
LQZ 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

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

Vivos DNA by Johns Dental Laboratory — 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
Johns Dental Laboratory

Sources (1)

  • FDA UDI 016adf6b-2358-487c-a2c2-cf5e519f7a8b 33 fields · synced May 30, 2026