Vivos DNA-Lower

GUDID 00810002220159

Lower 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 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 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 ID: 00810002220159
• NIH Device Record Key: a54ff347-f362-4e77-888d-78171beb6dc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivos DNA-Lower
• Version Model Number: 3014680794
• Company DUNS: 016649253
• Company Name: JOHN'S DENTAL LABORATORY INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810002220159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160477

FDA Product Code

• OCO: Mouthguard, Migraine/Tension Headache

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-21
• Device Publish Date: 2022-06-13