The Silencer

GUDID 00810002220258

A removable intraoral device designed to treat mild - moderate sleep apnea and snoring. This is a reusable device.

JOHN'S DENTAL LABORATORY INC

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00810002220258
• NIH Device Record Key: fbee9d70-139a-44d4-bce8-eb39cc455890
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Silencer
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810002220258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954530

FDA Product Code

• LRK: Device, Anti-Snoring

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: 2023-04-11
• Device Publish Date: 2023-04-03