EndSnorZ Sleep Appliance ENDSNZU

GUDID D745ENDSNZU0

EndSnorZ Sleep Appliance Upper Tray

Prismatik Dentalcraft, Inc

Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis
Primary Device IDD745ENDSNZU0
NIH Device Record Key0ae92a00-0451-4c65-8d36-532a1be90def
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndSnorZ Sleep Appliance
Version Model NumberENDSNZU
Catalog NumberENDSNZU
Company DUNS022761689
Company NamePrismatik Dentalcraft, Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD745ENDSNZU0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRKDevice, anti-snoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-23
Device Publish Date2024-04-15

On-Brand Devices [EndSnorZ Sleep Appliance]

D745ENDSNZU0EndSnorZ Sleep Appliance Upper Tray
D745ENDSNZL0EndSnorZ Sleep Appliance Lower Tray
D745ENDSNZ0EndSnorZ Sleep Appliance

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