Vivos DNA

GUDID 00810002220012

Mouth guard, migraine/tension headache, Jaw repositioning device

JOHN'S DENTAL LABORATORY INC

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 00810002220012
• NIH Device Record Key: 3354d9f5-038d-45d7-867b-28ea18a78a8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivos DNA
• 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: true
• 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	00810002220012 [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: 2020-09-16
• Device Publish Date: 2020-09-08