FDA.reportPublic FDA data

SnoreByte Kit

Primary DI
B140035202
Brand
SnoreByte Kit
Company
Braebon Medical Corporation
Model
3520-5
Catalog number
3520-5
Device 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.
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082849000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082849000SILENT SLEEPCraniofacial Pain Center of Idaho2009-07-16LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B140035202PrimaryHIBCC0
B140035201Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosisA removable intraoral device designed alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning the lower jaw (mandible), frequently in a downward and forward position, and by elevating the soft palate (soft tissue constituting the back of the roof of the mouth). It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding and by applying pressure to lift a drooping soft palate, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
6138316690info@braebon.com

Regulatory Flags#

DUNS number
251731105
Device count
5
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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B1400580D0BRAEBON PT2 Dual Differntial Airflow Pressure Kit0580D0580D2016-09-22
B1400580PES0BRAEBON Ultima Esophageal Pressure Transducer0580PES0580PES2016-09-22
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B1400580A0BRAEBON PT2 Dual Differntial Airflow Pressure Kit for Alice0580A0580A2016-09-22
B1408130201MediByte Electrode Prep Kit8130-208130-202019-11-08
B140BM5598501Divided Nasall Cannula + Filter, PediatricBM5598-50BM5598-502019-11-08
B1400582MCO2501Ultima Divided Nasal Cannula + Filter0582MCO2-500582MCO2-502019-10-25
B1400582MCO2PED501Ultima Divided Nasal Cannula + Filter, Pediatric0582MCO2-PED-500582MCO2-PED-502019-10-25
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Primary DI, Brand, Company table
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