mmRNA appliance

GUDID 00810002220111

The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep.

JOHN'S DENTAL LABORATORY INC

Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard 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 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 ID00810002220111
NIH Device Record Key883827ef-fb0d-492d-8a88-0fc5c8548b72
Commercial Distribution StatusIn Commercial Distribution
Brand NamemmRNA appliance
Version Model Number3014680794
Company DUNS016649253
Company NameJOHN'S DENTAL LABORATORY 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 Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810002220111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-14
Device Publish Date2022-02-04