Vivos DNA-Lower

GUDID 00810002220159

Lower mouth guard, migraine/tension headache, Jaw repositioning device

JOHN'S DENTAL LABORATORY INC

Dental appliance fabrication material, thermoplastic
Primary Device ID00810002220159
NIH Device Record Keya54ff347-f362-4e77-888d-78171beb6dc9
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivos DNA-Lower
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 Productfalse
Single Usefalse
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
GS100810002220159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCOMouthguard, Migraine/Tension Headache

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-21
Device Publish Date2022-06-13