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SnoreByte Kit

FDA UDI

Class II (US FDA UDI)

by Braebon Medical Corp.

Identity

Trade Name
SnoreByte Kit FDA UDI
Generic Name
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis FDA UDI
Device Name
Kit including the Silent Sleeep tray, intended as a temporary or trial device in the treatment of snoring or obstructive sleep apnea. Kit contains mixing tip, Silent Sleep Tray, toothbrush, OrthoFresh. FDA UDI
Model / Reference
3520-5 FDA UDI
Description
Kit including the Silent Sleeep tray, intended as a temporary or trial device in the treatment of snoring or obstructive sleep apnea. Kit contains mixing tip, Silent Sleep Tray, toothbrush, OrthoFresh. FDA UDI

Identifiers

Catalog Number
3520-5 FDA UDI
Primary DI / UDI-DI
B140035202 FDA UDI
510(k) Number
K082849 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

Yes

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

Yes

FDA UDI

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

SnoreByte Kit by Braebon Medical Corp. — 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

K082849 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Braebon Medical Corp.

Sources (1)

  • FDA UDI 36827709-bcb7-4dfa-b188-dfb8544c96dc 36 fields · synced May 30, 2026