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Breathe Easy EMA

FDA UDI

Class II (US FDA UDI)

by Allesee Aoa-Pro

Identity

Trade Name
Breathe Easy EMA FDA UDI
Generic Name
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis FDA UDI
Device Name
Sleep EMA (Enoch) - Preformed Tooth Positioner FDA UDI
Model / Reference
3000-0133 FDA UDI
Description
Sleep EMA (Enoch) - Preformed Tooth Positioner FDA UDI

Identifiers

Primary DI / UDI-DI
00889989075052 FDA UDI
510(k) Number
K070327 FDA UDI
FDA Product Code
LRK FDA UDI
GMDN Term
Mandible-repositioning/palate-lifting 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

No

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

Category: Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis

Breathe Easy EMA by Allesee Aoa-Pro — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis.

Cleared under the same submission

K070327 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Allesee Aoa-Pro

Sources (1)

  • FDA UDI bb7debde-f2b2-4d9c-a6be-1f3ea1be052a 35 fields · synced Jun 8, 2026