Vivos DNA

GUDID 00810002220012

Mouth guard, migraine/tension headache, Jaw repositioning device

JOHN'S DENTAL LABORATORY INC

Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic
Primary Device ID00810002220012
NIH Device Record Key3354d9f5-038d-45d7-867b-28ea18a78a8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivos DNA
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 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
GS100810002220012 [Primary]
GS100810002220012 [Primary]
GS100810002220012 [Primary]
GS100810002220012 [Primary]
GS100810002220012 [Primary]
GS100810002220012 [Primary]
GS100810002220012 [Primary]
GS100810002220012 [Primary]
GS100810002220012 [Primary]
GS100810002220012 [Primary]
GS100810002220012 [Primary]
GS100810002220012 [Primary]
GS100810002220012 [Primary]
GS100810002220012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCOMouthguard, Migraine/Tension Headache
OCOMouthguard, Migraine/Tension Headache
OCOMouthguard, Migraine/Tension Headache
OCOMouthguard, Migraine/Tension Headache
OCOMouthguard, Migraine/Tension Headache
OCOMouthguard, Migraine/Tension Headache
OCOMouthguard, Migraine/Tension Headache
OCOMouthguard, Migraine/Tension Headache
OCOMouthguard, Migraine/Tension Headache
OCOMouthguard, Migraine/Tension Headache
OCOMouthguard, Migraine/Tension Headache
OCOMouthguard, Migraine/Tension Headache
OCOMouthguard, Migraine/Tension Headache
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 Date2020-09-16
Device Publish Date2020-09-08